For about a week after treatment, you may have some pain or swelling in the area between your scrotum and rectum, and your urine may be reddish-brown. As input, the 6 contours were each treated as their own channel in the image analogous to how RGB images are treated as 3 Adjustable flange brass rail channels in an image. Acute and proocols complications after hypofractionated intensity modulated radiotherapy in prostate cancer. Moreover, we have used a 2. Medical physics 39— prosfate We have developed a novel application of the fully convolutional deep network model, U-net, for dose prediction. American Association of Physicists in Imrt prostate protocols Introduction Radiation therapy has been one of the leading treatment methods for cancer patients, and with the advent and advancements of innovative modalities, such as intensity modulated radiation therapy IMRT 1234567 and volume Beauty pageant hair secret Imrt prostate protocols therapy VMAT 891011121314plan quality has drastically improved over the last few decades. One particular area was the progression of convolutional neural network CNN 41 architectures for imaging and vision purposes 4243 This limits the amount of damage to nearby healthy tissues.
Reviews of penile nlargement. INTRODUCTION
The investigators stated that no significant differences between treatment groups were found in patient reported breast discomfort, breast hardness or quality of life. Patients Imrt prostate protocols prostatectomy should be counseled accordingly. Dysphagia and aspiration after chemoradiotherapy for head-and-neck cancer: Which anatomic structures are affected and can they be spared by IMRT? They prefer this technique protocls post-surgical RT because it allows for improved localization of the target area allowing for the maximal delivery of protocolw radiation dose while minimizing exposure of surrounding normal tissues. The orotocols active surveillance literature Imrt prostate protocols 23 prospective studies. Initial focal therapy reports with short term follow-up suggest effective disease eradication in the treated area of appropriately selected patients. Radiation treatment may be associated with a very small but increased risk for secondary cancer, specifically bladder cancer and rectal cancer. Conflicting data exist regarding the possibility that serial biopsies may be associated with accelerated declines in these domains. Guidelines cannot include evaluation of all data on emerging technologies Safety first chastity belt art management, including those that are FDA-approved, which may immediately come to represent accepted clinical practices. The most commonly used radiological treatment is conventional fractionated radiation. Let your doctor know if you would like to have children after treatment. Semin Radiat Oncol. Notably, urinary incontinence subsides to prostatte small to no bother for most men by one year post-prostatectomy.
We evaluated long-term outcomes of three protocols of intensity-modulated radiation therapy IMRT for localized prostate cancer.
- Additional information includes the clinical notes related to the specific recommendation.
- Intensity-modulated radiation therapy, or IMRT, is a type of cancer treatment that uses advanced computer programs to calculate and deliver radiation directly to cancer cells from different angles.
- Radiation therapy uses invisible, high-energy radiation to destroy cancer cells.
Help us improve our products. Sign up to take part. A Nature Research Journal. With the advancement of treatment modalities in radiation therapy for cancer patients, outcomes have improved, but at the cost of increased treatment plan complexity and planning time. The accurate prediction of dose distributions would alleviate this issue by guiding clinical plan optimization to save time and maintain high quality plans.
We have modified a convolutional deep network model, U-net originally designed for segmentation purposes , for predicting dose from patient image contours of the planning target volume PTV and organs at risk OAR.
We show that, as an example, we are able to accurately predict the dose of intensity-modulated radiation therapy IMRT for prostate cancer patients, where the average Dice similarity coefficient is 0. As an additional advantage, relatively little data was used in the techniques and models described in this paper.
Radiation therapy has been one of the leading treatment methods for cancer patients, and with the advent and advancements of innovative modalities, such as intensity modulated radiation therapy IMRT 1 , 2 , 3 , 4 , 5 , 6 , 7 and volume modulated arc therapy VMAT 8 , 9 , 10 , 11 , 12 , 13 , 14 , plan quality has drastically improved over the last few decades. However, such a development comes at the cost of treatment planning complexity.
While this complexity has given rise to better plan quality, it can be a double-edged sword that increases the planning time and obscures the tighter standards that these new treatment modalities are capable of meeting. This has resulted in greatly increased clinical treatment planning time, where the dosimetrist goes through many iterations to adjust and tune treatment planning parameters, as well as receiving feedback from the physician many times before the plan is approved.
Many further developments in treatment planning algorithms have aided in reducing the treatment complexity, such as including dose-volume constraints in a feasibility seeking algorithm 15 , creation of many Pareto surface plans for the planner to navigate through 16 , 17 , 18 , and many others for performance improvements and usage simplification 19 , 20 , 21 , 22 , 23 , 24 , However, using any of these algorithms still requires intelligent inputs or tweaks from the human planner, such as weight tuning, deciding appropriate DVH constraints or determining appropriate tradeoffs.
To reduce the planning complexity even further, the prediction of dose distributions and constraints has become an active field of research, with the goal of creating consistent plans that are informed by the ever-growing body of treatment planning knowledge, as well as guiding clinical plan optimization to save time and to maintain high quality treatment plans across planners of different experiences and skill levels.
Overall workflow does not change, but we expect the number of iterations to considerably decrease. A Current treatment planning workflow. B Proposed workflow with AI-based dose prediction.
Less iterations denoted as dotted-blue lines. Although much time and effort has been spent in selecting handcrafted features—such spatial information of organs at risk OAR and planning target volumes PTV , distance-to-target histograms DTH , overlapping volume histograms OVH , structure shapes, number of delivery fields, etc.
Artificial neural networks have been applied to learn more complex relationships between the handcrafted data 31 , but it is still limited by the inherent information present in that data. Another known KBP approach by Good et al. The success of such a method relies on the size and diversity of its patients, and may possibly be limited when faced with more complex treatment sites, such as head and neck cancer patient.
In the last few years, deep learning has made a quantum leap in the advancement of many areas. One particular area was the progression of convolutional neural network CNN 41 architectures for imaging and vision purposes 42 , 43 , In , fully convolutional networks FCN 45 were proposed, and outperformed state-of-the-art techniques of its time at semantic segmentation.
Shortly after, more complex models were built around the FCN concept in order to solve some of its shortcomings. One particular architecture that was proposed is a model called U-net 46 , which focused on the semantic segmentation on biomedical images.
While inserting some domain knowledge into the problem may be helpful due to a limited amount of data, we look towards deep learning to reduce our dependence on handcrafted features, and allow the deep network to learn its own features for prediction. Even though the U-net and other FCN architectures were designed for the task of image segmentation, we hypothesize that, with some innovative modifications, the U-net architecture will be able to accurately predict a voxel-level dose distribution simply from patient contours, by learning to abstract its own high-level local and broad features.
Our motivation is two-fold: 1 short term motivation to provide guidance for the dosimetrist during clinical plan optimization in order to improve the plan quality and uniformity and, to reduce the total planning time by decreasing the number of iterations the dosimetrist has to go through with the physician and treatment planning optimization, and 2 long term motivation to eventually develop an artificial intelligent treatment planning tool, capable of creating entire clinically acceptable plans.
Specifics of the input data is outlined in Section 2. Zero padding was added to the convolution process so that the feature size is maintained.
Batch normalization 48 BN was added after the convolution and rectified linear unit ReLU operations in the U-net, which allows for a more equal updating of the weights throughout the U-net, leading to faster convergence.
Schematic of an example U-net architecture with additional CNN layers used for dose prediction. The numbers above the boxes represent the number of features for each map, while the numbers to the left of each hierarchy in the U-net represents the size of each 2D feature.
The choice for the dropout parameters was determined empirically, until the gap between the validation loss and training loss did not tend to increase during training. The Adam algorithm 50 was chosen as the optimizer to minimize the loss function. In total, the network consisted of 46 layers.
The deep network architecture was implemented in Keras 51 with Tensorflow 52 as the backend. The 7 IMRT beam angles were similar across the 88 patients. Each patient had 6 contours: planning target volume PTV , bladder, body, left femoral head, right femoral head, and rectum. For training, all patient doses were normalized such that the mean dose delivered to the PTV was equal to 1. The U-net model was trained on single slices of the patient. As input, the 6 contours were each treated as their own channel in the image analogous to how RGB images are treated as 3 separate channels in an image.
The loss function was chosen to be the mean squared error between the predicted dose and the true dose delivered to the patient. Since the central slices containing the PTV were far more important than the edge slices for dose prediction, we implemented a Gaussian sampling scheme—the center slice would more likely be chosen when the training function queried for another batch of random samples.
The distance from the center slice to the edge slice was chosen to equal 3 standard deviations for the Gaussian sampling. Each of the 10 folds divides the remaining 80 patients into 72 training patients and 8 validation patients.
Ten separate U-net models are initialized, trained, and validated on a unique training and validation combination. Each fold produces a model that can predict a dose distribution from contours.
From these 10 trained models, we then take the best performance model, based on its validation loss, and evaluate this model on the test set. Schematic for fold cross-validation. A test set is held out from the cross validation procedure, and is used to test the best performance model. For the remainder of the manuscript, some common notation will be used. V ROI is the volume of the region of interest. Isodose volumes are binary masks defined as 1 if the voxel contains a dose value above some threshold and 0 otherwise.
It should be noted that this is normalized differently than for training the model, which had normalized the plans by PTV mean dose. Normalizing by PTV mean dose creates a uniform dataset which is more likely to be stable for training, but plans normalized by D95 have more clinical relevance and value for assessment. All dose statistics will also be reported relative to the prescription dose i.
One GPU was used for training each fold of the fold cross-validation. Training batch size was chosen to be 24 slices. All patient data has been fully anonymized, and all methods were performed in accordance with the relevant guidelines and regulations outlined by the institution. Since gathered patient data was retrospective and did not directly involve the human participants during the study, informed consent is not applicable to this study.
In total, models from all folds trained for epochs each, which took approximately 6 days on the 10 GPUs. Of the 10 folds, the model from the 5 th fold performed the best with the lowest validation loss of 4. This model was used to evaluate the dosimetric performance on the test set of patients.
On average, the U-net model is biased to slightly over-predict the mean and max doses. Overall, the cross validation error is slightly less than the test error. The bladder has a low max dose error of 1. Overall, the model is capable of accurately predicting D max and D mean within 5. Contours of the planning target volume PTV and organs at risk OAR , true dose wash, predicted dose wash, and difference map of an example patient. Example of typical dose volume histogram DVH comparing true dose and predicted dose for one patient.
Dice similarity coefficients range from 0 to 1, where 1 is considered a perfect match. The average Dice similarity coefficient for the test data is 0. The error in the graph represents 1 standard deviation. The finer details of the dose distributions further away from the PTV have been predicted by the deep network model with relative high accuracy. Example dose predictions from the U-net model on several patients with vastly different geometries. To our knowledge, this is the first fully 3D dose distribution prediction for prostate IMRT plans, thus making direct comparison to existing models difficult.
The latest study by Shiraishi and Moore 31 on knowledge based planning did investigate 3D dose prediction, but for prostate patients treated with VMAT. In addition, another cutting edge study by McIntosh and Purdie 54 investigated 3D dose prediction using atlas regression forests. Therefore, our impression is that our predictive model is at least within the same ballpark as the cutting edge methods by these authors. The 88 clinical prostate patients acquired in this study used a similar set of 7 beam angles and criteria for treatment, giving rise to some uniformity to the data that made it ideal as a test bed to investigate the feasibility for dose prediction using a deep learning model.
However, the current model architecture and data leave the U-net with several limitations. First, the model has currently learned to only predict the dose coming from approximately the same orientations, and may not be able to account for more intricate beam geometries.
Secondly, the current model is unable to account for any physician preferences for predicting the dose, limiting the level of treatment personalization for the patient. For example, the model is unable to create a rectum-sparing plan or a bladder-sparing plan, at the will of the physician, for the same patient geometry.
Furthermore, while training slice-by-slice had proven successful for coplanar cases, this method may not perform satisfactorily when performing dose prediction for non-coplanar plans. The deep network may have to understand the patient geometry in 3D if it were to start accounting for non-coplanar beam dose.
Nevertheless, because the clinical prostate IMRT protocol is standardized, the current dose prediction model from this study can still be employed as a clinical guidance tool, where final tradeoff decisions will still be made by the physician and dosimetrist. By utilizing this model, the physician can immediately view the dose prediction and then convey how they desire for the plan to be changed to the dosimetrist.
By already having a tangible plan to view, the dosimetrist can more readily apply the changes to make an acceptable plan earlier and ultimately reduce the total planning time. We plan to extend this study by building a deep learning model for learning dose predictions that is capable of handling a more diverse selection of non-coplanar beam orientations. Furthermore, we will examine the addition of CT data and its effect on prediction accuracy.
We expect the addition of such information to the model will greatly improve the prediction accuracy, and will investigate the impact of adding these types of information.
There are no evidence-based guidelines from leading national medical organizations or Federal public health agencies that conclude that IMRT is routinely indicated for breast cancer. It reported a progression-free survival PFS of 6. Moreover, the Panel agreed that most patients should be offered the opportunity to delay therapy for a few months to allow them time to lose weight or stop smoking to reduce these perioperative risks as long as doing so does not significantly impair cancer control. Clinical Practice Guidelines in Oncology Version 2. The target volume is concave or convex, and the critical normal tissues are within or around that convexity or concavity. It is also a challenge to reduce the variation between clinicians.
Imrt prostate protocols. Radiation therapy
At the beginning of each treatment session, a radiation therapist will position you on a treatment table, placing marks on your skin to guide where he or she will deliver the radiation treatment. Treatment sessions are painless. IMRT requires multiple sessions. Typically, you will have IMRT sessions five days a week for several weeks.
IMRT allows the radiation dose to conform more precisely to the three-dimensional shape of the tumor by changing — modulating — the radiation beam into multiple smaller beams. This enables a higher dose of radiation to be delivered to the tumor while sparing healthy tissue around it. To deliver these smaller beams, the machine forms the radiation into varying shapes throughout the course of treatment.
Our researchers developed IMRT in for the treatment of prostate cancer. Since then, we have advanced its use for many other types of cancer and made many improvements to the technology and the way that treatment is delivered. IMRT remains a powerful tool for fighting many types of cancer.
Our radiation oncologists , nurses, and therapists are trained to treat specific types of cancers. This increases our chances of controlling or curing your disease. Interventional Radiology. Radiation Therapy. Overview What Is Brachytherapy? The studies contain varying eligibility criteria. While each was designed to identify patients with favorable prognoses, and thus good candidates for active surveillance, the clinical criteria applied at different sites and in different studies vary.
They each include early clinical stage, low serum PSA, and Gleason score consistent with well- or moderately-differentiated tumors.
Beyond these three core components, many incorporate number and percentage of positive cores, extent of tumor involvement within a biopsy core, PSA density, and kinetics. PSA density has been recognized by many groups as a biomarker for higher-risk disease. Although not universally accepted, several sites recommend repeat prostate biopsy before committing to active surveillance in order to identify patients where initial biopsies may have missed higher-risk features.
In most patients, delaying this biopsy for six months to a year is unlikely to have an impact on long term outcome, even if higher-grade disease is later identified. Eligibility criteria heterogeneity reflects a different risk tolerance between investigators. For those centers with more inclusive criteria, the potential advantages of surveillance outweigh what is believed to be a small increased risk of metastasis occurring while being surveilled.
The increased progression rate likely reflected the inclusion of higher-risk patients in the cohort. Several decision analyses suggest that it would require a substantial increase in prostate cancer mortality under surveillance compared to radical intervention before surveillance would lose the net benefit for low and intermediate risk groups. Surveillance follow up strategies differ depending on study center. Although the key parameters available for monitoring include PSA, DRE, and repeat prostate biopsy, no group has defined the appropriate criteria to trigger active intervention or testing intervals.
Biopsy intervals vary from one to five years. Clinicians may consider multiparametric prostate MRI as a component of active surveillance for localized prostate cancer patients.
Finally, MRI appears to be useful in detecting occult clinically significant disease among active surveillance candidates whose initial biopsy demonstrates only Gleason 6 disease. If it is employed, mpMRI should be performed on at minimum a 1. The Panel does not recommend the use of mpMRI in place of prostate biopsy at this time. Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up.
The lethal potential of prostate cancer is difficult to predict with precision based on stage, grade, and PSA level. The presence of only Gleason pattern 3 predicts for a favorable clinical outcome. Earlier identification of patients with co-existent higher-grade cancer is a major unmet need in the field. The challenge for tissue-based genetic tests is to provide more accurate risk stratification than currently available optimally used clinical tools and predictive modeling in a way that is reasonably cost effective.
RNA expression profiles of selected gene panels can be performed on small samples of cancer in biopsy specimens to predict prognosis more accurately. Genomic analyses of prostate cancer reveal distinct patterns of alterations in the genotype that may predict prognosis more accurately. While such assays have sufficient analytic and clinical validity, their clinical utility in active surveillance remains to be established.
In particular, these assays were validated in the pre-MRI era. Their incremental value in the context of men who have had a mpMRI is unclear.
An additional concern regarding the use of biopsy-based molecular biomarkers is the sampling error inherent in prostate biopsy given known tumor heterogeneity. The proportion of men whose clinical risk category is substantially altered by molecular tests, particularly in men with low-risk disease, is relatively minor.
Clinicians should offer definitive treatment to localized prostate cancer patients undergoing active surveillance who develop adverse reclassification. This may be due either to an incorrect original classification or to true progression from a lower-risk to a higher-risk category.
Clinicians should inform localized prostate cancer patients that younger or healthier men e. Compared to other cancers, prostate cancer is typically a slowly evolving disease. Numerous studies exploring its natural history have suggested that, even if high-grade and left untreated, disease specific survival is a median of years after diagnosis. It is also unlikely that clinical trials following patients for a shorter interval than years will be able to demonstrate a survival advantage attributable to the intervention being studied.
Two other studies with short follow up failed to demonstrate that age was significantly associated with survival after radical prostatectomy. Clinicians should inform localized prostate cancer patients that open and robot-assisted radical prostatectomy offer similar cancer control, continence recovery, and sexual recovery outcomes.
Data from a prospective RCT in Australia found no difference in margin status between open and robotic approaches. Follow up was very limited in these patients, so long term outcomes are not known. Urinary incontinence is one of the most distressing side effects of radical prostatectomy, even when limited in duration and severity.
Multiple studies have found no statistical difference in the rates of continence after open, robotic, or perineal radical prostatectomy. All surgical approaches confer a risk of erectile dysfunction after radical prostatectomy, and this must be discussed with patients preoperatively.
There is no statistically significant difference in retrospective, prospective non-randomized, and prospective randomized trials in the rate and recovery of erectile function if an open, laparoscopic, or robotic assisted laparoscopic approach is used.
Radical prostatectomy has a risk of bleeding requiring transfusion whether it is performed open or via a minimally invasive approach, such as pure laparoscopic or robotic assisted laparoscopic surgery. Patients must be informed prior to surgery of this risk, and patient preferences regarding transfusion must be considered accordingly.
Two randomized trials found a lower rate of transfusion with minimally invasive approaches compared to open surgery. There were no intraoperative transfusions due to use of cell saver, but six patients in the open group had postoperative transfusions compared to one in the robotic group.
The Health Professionals follow up study similarly found a lower estimated blood loss ml versus ml and a lower transfusion rate 4. Early experience with radical prostatectomy was marked by large intraoperative blood loss and near-certain postoperative erectile dysfunction. Advances in anatomic understanding of pelvic anatomy and advances in surgical technique allowed for the preservation of the neurovascular bundles containing the cavernous nerves responsible for penile tumescence.
Prospective registries have demonstrated that nerve-sparing prostatectomy improved post-operative sexual function as well as overall QoL.
Clinicians should not treat localized prostate cancer patients who have elected to undergo radical prostatectomy with neoadjuvant ADT or other systemic therapy outside of clinical trials.
Four randomized prospective studies compared three months of neoadjuvant ADT followed by radical retropubic prostatectomy to radical prostatectomy alone. Therefore, there is no long-term oncologic benefit to adding neoadjuvant ADT to radical prostatectomy for localized prostate cancer. A randomized, prospective study of neoadjuvant docetaxel combined with ADT followed by radical prostatectomy compared to radical prostatectomy alone for high risk prostate cancer is ongoing, so this combination is still considered investigational.
Clinicians should inform localized prostate cancer patients considering prostatectomy, that older men experience higher rates of permanent erectile dysfunction and urinary incontinence after prostatectomy compared to younger men. Patient age has been recognized to be a key determinant of post-prostatectomy sexual recovery since the earliest studies of nerve-sparing prostatectomy by Walsh, and the pivotal role of patient age as an indicator of erectile function recovery has been validated in two multicenter prospective cohorts CaPSURE and PROSTQA.
Patients considering prostatectomy should be counseled accordingly. Older age has also been shown to reduce the pace and extent of post-prostatectomy urinary continence recovery.
Pelvic lymphadenectomy can be considered for any localized prostate cancer patients undergoing radical prostatectomy and is recommended for those with unfavorable intermediate-risk or high-risk disease. Patients should be counseled regarding the common complications of lymphadenectomy, including lymphocele development and its treatment. Pelvic lymphadenectomy PLND is the most effective means of detecting nodal metastases.
Variability in the reported rates of nodal metastases reflects both primary tumor characteristics and the extent of PLND. Several reports have clearly shown that extended PLND is associated with a higher lymph node detection rate as compared with limited PLND, regardless of prostate cancer aggressiveness.
Evidence is lacking as to whether or not the removal of lymph nodes containing metastatic prostate cancer has therapeutic benefit. In lymphoceles refractory to percutaneous drainage and sclerosis, minimally invasive marsupialization of the lymphocele is recommended. These side effects subsided to no difference between the treatment arms at five years. Clinicians may offer single modality external beam radiotherapy or brachytherapy for patients who elect radiotherapy for low-risk localized prostate cancer.
While active surveillance is the preferred management strategy, radiotherapy can be considered as an alternative for low-risk prostate cancer in patients who select treatment at diagnosis or during follow-up. SBRT generally utilizes photon-based IMRT treatment to deliver hypofractionated radiation treatment usually in five or fewer fractions of treatment. Low-dose rate brachytherapy utilizes radioactive seeds that are implanted based of pretreatment and intraoperative image-guidance according to a computer plan.
High-dose rate brachytherapy uses temporary catheters implanted in the prostate to allow for the delivery of a high-activity radiation source. All allow for the delivery of highly conformal radiotherapy. There is no evidence that combinations of therapies are required for the treatment of low-risk prostate cancer given the low-risk of extra capsular disease extension and the favorable biochemical control rates associated with the use of monotherapy. Clinicians may offer external beam radiotherapy or brachytherapy alone or in combination for favorable intermediate-risk localized prostate cancer.
Radiotherapy can be considered as an appropriate option for intermediate-risk prostate cancer. Results of the RTOG trial assessing low-dose brachytherapy with and without EBRT have been reported and published in abstract form while complete findings are awaited. Clinicians should offer months of ADT as an adjunct to either external beam radiotherapy alone or external beam radiotherapy combined with brachytherapy to patients electing radiotherapy for high-risk localized prostate cancer.
Based on these trials, acceptable ADT durations for radiotherapy patients with high-risk prostate cancer range from months. A randomized trial that compared radiotherapy plus 18 versus 36 months ADT in high-risk patients has not been published with mature data; at this time it is unknown if 18 months of ADT is an acceptable duration.
There are little data of long-term efficacy of SBRT in high-risk prostate cancer, and this modality is not recommended. In high-risk patients without evidence of nodal metastasis based on imaging, radiation treatment may electively include pelvic nodal areas because published nomograms demonstrate that these patients have a risk of harboring micrometastatic nodal disease.
Whether pelvic radiotherapy improves survival is the subject of a current randomized trial. Prior randomized trials comparing prostate-only versus prostate and pelvic radiation treatment have not demonstrated improved survival from electively adding pelvic radiation. Clinicians should inform localized prostate cancer patients that use of ADT with radiation increases the likelihood and severity of adverse treatment-related events on sexual function in most men and can cause other systemic side effects.
ADT can cause sexual side effects, hot flashes, decreased bone mineral density, gynecomastia, depression, fatigue, and weight gain. A variety of strategies have been studied to help mitigate these effects. There is a risk of non-recovery of testosterone in a subset of patients after ADT. Clinicians should consider moderate hypofractionation when the localized prostate cancer patient of any risk category and clinician decide on external beam radiotherapy to the prostate without nodal radiotherapy.
Traditionally, radical EBRT is usually delivered with standard daily fractionation schedules with about 1. The alpha-beta ratio is the dose where cell killing due to the linear and quadratic components are equal. There is mounting evidence that certain tumors e. Recently, a series of RCTs have been published to inform the potential of moderate hypofractionation given with modern radiation technology as well as what is considered by many to be adequate doses to optimize biochemical control in both the standard 1.
No differences in side effects were noted between the study groups. The short-term non-inferiority of modern moderate hypofractionated external beam radiotherapy have been replicated in two other non-published RCTs; however, the main limitation of these studies is the lack of long-term follow-up in terms of clinically important cancer control and toxicity outcomes. Patients at risk for late effects of radiotherapy including but not limited to pre-existing lower urinary tract symptoms [LUTS], transurethral resection of the prostate [TURP], and anticoagulant usage may be better served with conventional fractionation 1.
For localized prostate cancer patients with obstructive, non-cancer-related lower urinary function, surgical approaches may be preferred. If radiotherapy is used for these patients or those with previous significant transurethral resection of the prostate, low-dose rate brachytherapy should be discouraged. Relative contraindications to EBRT and brachytherapy include inflammatory bowel disease and history of prior pelvic radiotherapy due to increased risk for treatment-related morbidity.
Clinicians should inform localized prostate cancer patients who are considering proton beam therapy that it offers no clinical advantage over other forms of definitive treatment. In the specific context of prostate cancer, very limited information exists in relation to the comparative effectiveness of proton therapy compared to other radiation techniques or other modalities of treatment.
Clinicians should inform localized prostate cancer patients considering brachytherapy that it has similar effects as external beam radiotherapy with regard to erectile dysfunction and proctitis but can also exacerbate urinary obstructive symptoms. Prospective QoL research showed that both EBRT and brachytherapy led to modest rates of bloody stools, rectal pain, and overall bowel problems.
Cryosurgery can be an appropriate treatment option for men with intermediate-risk prostate cancer who are not suitable candidates for prostatectomy i.
Neither RCT was powered to evaluate comparative cancer-specific or overall mortality. However, sample size and duration of follow-up was insufficient to determine whether or not cryosurgery has long-term cancer-specific or overall survival efficacy comparable to EBRT. Prostate gland volume is a factor in patient selection in that it can be difficult to achieve uniform cold temperatures throughout the organ. Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery that cryosurgery has similar progression-free survival as did non-dose escalated external beam radiation also given with neoadjuvant hormonal therapy in low- and intermediate-risk disease, but conclusive comparison of cancer mortality is lacking.
One randomized clinical trial of non-dose escalated EBRT versus cryosurgery has been reported for localized prostate cancer with primarily intermediate- and high-risk disease patients and in each arm respectively. However, the study was not powered to compare cancer survival or overall survival, and long-term data beyond 10 years are also lacking. Of note, even though neoadjuvant ADT was consistently given with cryosurgery in the two trials that compared cryosurgery to radiotherapy, neoadjuvant ADT in cryosurgery has not been demonstrated to improve oncologic outcomes compared to cryotherapy alone.
At three years, the cryosurgery patients reported slightly lower sexual function, slightly better urinary function, and comparable bowel function outcomes in comparison to the EBRT patients. Defects from prior transurethral resection of the prostate are a relative contraindication for whole gland cryosurgery due to the increased risk of urethral sloughing. The urethral warming catheter may fail to fully contact the urethral mucosa in patients with a TURP defect increasing the likelihood for urethral necrosis, sloughing, dysuria, and urinary retention.
For whole gland cryosurgery treatment, clinicians should utilize a third or higher generation, argon-based cryosurgical system for whole gland cryosurgery treatment. Optimal oncologic and QoL outcomes of whole gland cryosurgery are achieved with a third generation, argon-based cryosurgical system. In addition to a urethral warming catheter, real-time ultrasound monitoring of the advancing ice ball is recommended.
The Panel is unaware of any conclusive studies evaluating whether or how the use of concurrent ADT enhances or mitigates the oncologic efficacy of cryosurgery. Nevertheless, the addition of ADT to cryosurgery is common. Two randomized trials of EBRT versus cryosurgery have been reported with primarily intermediate-risk, high-risk, or locally advanced disease patients. Both utilized 6 months of perioperative ADT for both treatment arms.
One study of primarily localized prostate cancer reported similar actuarial 5-year overall and disease —specific survival. Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery that erectile dysfunction is an expected outcome. Available evidence has shown that erectile dysfunction should be expected the usual outcome for potent patients undergoing whole gland ablation.
Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery about the adverse events of urinary incontinence, irritative and obstructive urinary problems. As with all treatments, in addition to the high risk of erectile dysfunction, patients considering cryosurgery should be informed about the risks of adverse urinary and bowel quality of life outcomes.
Urethral fistula with third generation cryosurgical systems and thermocouple monitoring is very rare 0. The Panel recommends that if HIFU is offered as an alternative treatment modality for localized prostate cancer, it should be done within the context of a clinical trial. Prospective randomized or comparative trials with other treatment modalities are lacking. Focal therapy is based on the concept that, although prostate cancer can present as multifocal disease within the prostate gland, some patients may have a significant single index intraprostatic lesion.
This index lesion may be associated with the most aggressive nidus of cancer within the gland and may be the most appropriate target for treatment. A prerequisite for focal therapy involves advanced mapping of lesions within the prostate.
This can be done with a saturation biopsy or, more commonly, with MRI imaging with focused biopsy or a 3-dimensional transperineal mapping biopsy to identify appropriate patients with clinically significant disease, to provide an appropriate index target, and to provide an appropriate target for follow-up scanning and biopsies. Focal therapy involves subtotal or zonal destruction of the prostate with cryosurgery, HIFU or other focally ablative techniques with the aim to minimize treatment toxicity.
The Panel acknowledges that focal ablative therapy is of significant interest to patients and clinicians as it may offer benefits in terms of QoL for selected patients with a solitary well-defined index lesion.
However, the Panel recommends that if focal therapy is offered as an alternative treatment modality for localized prostate cancer, it should only be done within the context of a clinical trial.
Initial studies with short term follow up suggest that effective disease eradication in the treated volume can be attained. The Panel recognizes that concern exists about the potential for undetected and, therefore, occult untreated clinically-significant multifocal disease.
Confirmation of oncologic effectiveness is currently lacking and will require prospective studies with long-term follow up. Clinicians should inform those localized prostate cancer patients considering focal therapy or HIFU that these treatment options lack robust evidence of efficacy.
However, there is a lack of consensus on objective response criteria, very limited long-term oncologic data, and, importantly, no comparative effectiveness data versus traditional treatments available. For patients with intermediate- and high-risk disease treated with HIFU, neoadjuvant ADT has been demonstrated to reduce PSA recurrence, but long-term oncologic effectiveness is unknown.
Patients should also be informed that the appropriate treatment for disease progression and the risk of metastatic progression remain undefined.
Most treatments for prostate cancer, such as surgery, radiation, and cryosurgery, predate mandated regulation by the FDA. Thus, by the time the FDA started to control what treatments could be delivered, all three of these treatments were grandfathered as approved for prostate cancer.
However, this was not the case for HIFU. Initial attempts were made to get HIFU approved for treatment of prostate cancer. However, due to poor accrual, this trial never completed. To date, HIFU is still not approved for treatment of prostate cancer.
As noted, no other modern treatment for prostate cancer had to obtain similar regulatory approvals. Thus, the fact that HIFU is not FDA approved for treating prostate cancer does not necessarily mean it is inferior to other treatments.
However, the fact that it is not approved has implications for patients. While discussion of costs of care is beyond the purview of the Panel, the Panel did agree that patients should be informed of the lack of FDA approval for treating prostate cancer and the potential implications of this ruling.
Clinicians should advise localized prostate cancer patients considering HIFU that tumor location may influence oncologic outcome. Limiting apical treatment to minimize morbidity increases the risk of cancer persistence. Physicians may have difficulty fully ablating anterior tumors in patients with prostate volumes greater than 40 g due to the limited focal length of the HIFU technology. Post-treatment MRI has demonstrated a margin of untreated anterior tissue in such patients.
However this can increase the risk of incomplete treatment in patients with apical tumors. Employing a 6 mm apical safety margin Boutier et al.
The mean prostate volume in virtually all HIFU series is less than 40 g. This is due to the limited focal length of the technology preventing the ability to treat anterior tumor extension, increase in procedure time, and higher rates of urinary retention. As prostate cancer is often multifocal, clinicians should inform localized prostate cancer patients considering focal therapy that focal therapy may not be curative and that further treatment for prostate cancer may be necessary.
The hypothesis of treating only the dominant lesion to minimize toxicity is attractive to the patient and clinician. The prevailing opinion is that patients should undergo a targeted and template post-treatment biopsy approximately one year after treatment to assess for residual viable cancer.
Clinicians should inform localized prostate cancer patients that erectile dysfunction occurs in many patients following prostatectomy or radiation, and that ejaculate will be lacking despite preserved ability to attain orgasm, whereas observation does not cause such sexual dysfunction. In counseling patients about potential QoL effects after different treatment options, it is important to provide data based on modern treatment technologies.
Because surgical and radiation technologies have evolved significantly over time, QoL results from patients treated in an older era likely do not represent the results of patients treated today. Time course of sexual dysfunction differs between radical prostatectomy and radiation treatment both EBRT and brachytherapy. Radical prostatectomy causes an immediate worsening of sexual function, with recovery over two years of time afterwards.
A study of patients diagnosed in and assessed long-term patient-reported QoL showed that sexual function was similar after radical prostatectomy and EBRT from 5 to 15 years after treatment. Non-treatment active surveillance or watchful waiting does not directly cause sexual dysfunction except for worsening of function and symptoms related to aging. Clinicians should inform localized prostate cancer patients that long-term obstructive or irritative urinary problems occur in a subset of patients following observation or active surveillance or following radiation, whereas prostatectomy can relieve pre-existing urinary obstruction.
Longer-term data comparing these side effects of cryosurgery and EBRT from this study are lacking. Three nonrandomized studies of lower quality compared cryosurgery to brachytherapy for urinary, bowel and sexual outcomes. In one study patients treated with brachytherapy had significantly more incontinence and sexual dysfunction, but less bowel events, than patients treated with cryosurgery.
Clinicians should inform localized prostate cancer patients that temporary urinary incontinence occurs in most patients after prostatectomy and persists long-term in a small but significant subset, more than during observation or active surveillance or after radiation. Urinary incontinence is a well-known side effect of radical prostatectomy. The magnitude of urinary incontinence is most profound in the first few months after prostatectomy, when incontinence is commonplace, during which time QoL in the urinary domain is significantly worse after prostatectomy then it is among patients who undergo radiotherapy or surveillance which are not associated with early incontinence.
Notably, urinary incontinence subsides to be small to no bother for most men by one year post-prostatectomy. This pattern of urinary incontinence and recovery following prostatectomy, contrasted to the pattern of obstructive and irritative symptoms during surveillance or after radiotherapy, has been demonstrated in multiple RCTs and prospective, multi-center cohorts alike.
Clinicians should inform localized prostate cancer patients that temporary proctitis following radiation persists in some patients long-term in a small but significant subset and is rare during observation or active surveillance or after prostatectomy.
Because surgical and radiation treatment technologies have evolved significantly over time, QoL results from patients treated in an older era likely do not represent the results of patients treated today.
A prospective randomized trial comparing active surveillance, radical prostatectomy, and 3D-conformal radiotherapy reported QoL outcomes in these three groups of patients. Bloody stools also increased modestly after radiotherapy, from 1. It is possible that with more modern radiation technology image guided radiotherapy , risk of proctitis could be less. Proctitis is not expected after radical prostatectomy or in patients who receive no treatment.
Clinicians should monitor localized prostate cancer patients post therapy with PSA, even though not all PSA recurrences are associated with metastatic disease and prostate cancer specific death. Initial therapy for localized prostate cancer is intended to cure the cancer. PSA surveillance after local therapy is recommended for at least 10 years with PSA frequency determined by risk of relapse and patient preferences for monitoring.
PSA monitoring beyond 10 years can be considered in men with high risk of relapse and long life expectancy. Patients should be informed that salvage therapies with potential for cure are available.
Salvage therapy after prostatectomy includes radiation with or without ADT. The cure rates for salvage radiation vary according to patient risk factors, such as Gleason score, time to PSA failure after prostatectomy, and PSA doubling time.
Salvage therapies after radiation are heterogeneous and include prostatectomy, HIFU, cryosurgery, and repeat radiation. Many of the post-radiation salvage approaches have either high potential for toxicity or low or unclear rates for cure and the pros and cons of localized salvage therapy after radiation should be carefully considered with the patient.
It is recommended that the treating physician carefully explain the goals of therapy and probability for cure. In addition the definitions of relapse after curative therapy should be outlined. It is important to educate the patient of the kinetics of testosterone recovery after ADT and expected concomitant rise in PSA. The natural history of relapsed prostate cancer is extremely variable.
The important clinical metrics include time to metastasis and death from prostate cancer. The definition of metastatic prostate cancer and a clear differentiation of the difference between PSA relapse, metastasis and death from prostate cancer should be explained to the patient.
In the setting of indolent PSA relapse it is paramount that the treating physician relieve patient stress and anxiety by educating the patient and family of the long natural history of relapsed marker only prostate cancer and in most cases the low chance of death from prostate cancer within 10 years of local therapy.
Clinicians should inform localized prostate cancer patients of their individualized risk-based estimates of post-treatment prostate cancer recurrence. An accurate assessment of the risks of failure and success for prostate cancer treatment are essential to good patient counseling and SDM. Clinicians should support localized prostate cancer patients who have survivorship or outcomes concerns by facilitating symptom management and encouraging engagement with professional or community-based resources.
Prostate cancer patients and survivors should also be offered available survivorship programs to help improve functional outcomes, psychological and other health needs. The extended time course between prostate cancer diagnosis and its eventual outcome poses challenges to the timeliness of ascertaining the efficacy of newer approaches to cancer risk ascertainment or therapeutic intervention. The maturation of evidence to provide robust guidance for optimizing care consequently lags the development of new technology.
Nevertheless, emerging evidence is anticipated in several key areas, while well-designed, multi-center studies are urgently needed in others. Emerging evidence is anticipated from follow up analyses of the ProtecT randomized trial comparing active surveillance, prostatectomy, and radiotherapy.
Data maturation may elucidate longer term outcomes i. Subsequent analyses of ProtecT also have the potential to further clarify the role of surveillance versus treatment between low and intermediate risk cancers.
Well-designed prospective studies are needed to optimize the utility of new imaging modalities e. The need to better characterize long-term HRQOL effects of ADT warrants special emphasis, as this treatment modality is part of the standard recommended radiotherapy care options for intermediate and high risk disease and is already broadly utilized. We need better evidence to council patients regarding the impact of adjuvant androgen deprivation on long-term HRQOL, despite recognition that effects on vitality, libido, and cognitive status can be substantial among patients undergoing ADT monotherapy.
To enable progress in prostate cancer care that is informed by the best evidence we must continue to prospectively evaluate new technologies as they are developed. Panel members were selected by the chair. The mission of the Panel was to develop recommendations that are analysis-based or consensus-based, depending on Panel processes and available data, for optimal clinical practices in the treatment of clinically localized prostate cancer.
Funding of the Panel was provided by the AUA. Each member of the Panel provides an ongoing conflict of interest disclosure to the AUA. While these guidelines do not necessarily establish the standard of care, AUA seeks to recommend and to encourage compliance by practitioners with current best practices related to the condition being treated.
As medical knowledge expands and technology advances, the guidelines will change. Today these evidence-based guidelines statements represent not absolute mandates but provisional proposals for treatment under the specific conditions described in each document.
For all these reasons, the guidelines do not pre-empt physician judgment in individual cases. Treating physicians must take into account variations in resources, and patient tolerances, needs, and preferences. Conformance with any clinical guideline does not guarantee a successful outcome. The guideline text may include information or recommendations about certain drug uses 'off label' that are not approved by the Food and Drug Administration FDA , or about medications or substances not subject to the FDA approval process.
AUA urges strict compliance with all government regulations and protocols for prescription and use of these substances. The physician is encouraged to carefully follow all available prescribing information about indications, contraindications, precautions and warnings. These guidelines and best practice statements are not in-tended to provide legal advice about use and misuse of these substances. Although guidelines are intended to encourage best practices and potentially encompass available technologies with sufficient data as of close of the literature review, they are necessarily time-limited.
Guidelines cannot include evaluation of all data on emerging technologies or management, including those that are FDA-approved, which may immediately come to represent accepted clinical practices. For this reason, the AUA does not regard technologies or management which are too new to be addressed by this guideline as necessarily experimental or investigational.
Expert Opinion Clinicians should encourage patients to meet with different prostate cancer care specialists e. Moderate Recommendation; Evidence Level: Grade B Effective shared decision making in prostate cancer care requires clinicians to inform patients about immediate and long-term morbidity or side effects of proposed treatment or care options.
Clinical Principle Clinicians should inform patients about suitable clinical trials and encourage patients to consider participation in such trials based on eligibility and access.
Strong Recommendation; Evidence Level: Grade C Clinicians should recommend active surveillance as the best available care option for very low-risk localized prostate cancer patients. Strong Recommendation; Evidence Level: Grade A Clinicians should recommend active surveillance as the preferable care option for most low-risk localized prostate cancer patients. Conditional Recommendation; Evidence Level: Grade B Clinicians should not add ADT along with radiotherapy for low-risk localized prostate cancer with the exception of reducing the size of the prostate for brachytherapy.
Strong Recommendation; Evidence Level: Grade B Clinicians should inform low-risk prostate cancer patients considering whole gland cryosurgery that consequent side effects are considerable and survival benefit has not been shown in comparison to active surveillance.
Conditional Recommendation; Evidence Level: Grade C Clinicians should inform low-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound HIFU that these interventions are not standard care options because comparative outcome evidence is lacking.
Strong Recommendation; Evidence Level: Grade B Among most low-risk localized prostate cancer patients, tissue based genomic biomarkers have not shown a clear role in the selection of candidates for active surveillance. Expert Opinion Intermediate-Risk Disease Clinicians should consider staging unfavorable intermediate-risk localized prostate cancer patients with cross sectional imaging CT or MRI and bone scan. Expert Opinion Clinicians should recommend radical prostatectomy or radiotherapy plus androgen deprivation therapy ADT as standard treatment options for patients with intermediate-risk localized prostate cancer.
Strong Recommendation; Evidence Level: Grade A Clinicians should inform patients that favorable intermediate-risk prostate cancer can be treated with radiation alone, but that the evidence basis is less robust than for combining radiotherapy with ADT.
Moderate Recommendation; Evidence Level: Grade B In select patients with intermediate-risk localized prostate cancer, clinicians may consider other treatment options such as cryosurgery. Conditional Recommendation; Evidence Level: Grade C Active surveillance may be offered to select patients with favorable intermediate-risk localized prostate cancer; however, patients should be informed that this comes with a higher risk of developing metastases compared to definitive treatment.
Strong Recommendation; Evidence Level: Grade A Clinicians should inform intermediate-risk prostate cancer patients who are considering focal therapy or HIFU that these interventions are not standard care options because comparative outcome evidence is lacking. Clinical Principle Clinicians should recommend radical prostatectomy or radiotherapy plus ADT as standard treatment options for patients with high-risk localized prostate cancer.
Strong Recommendation; Evidence Level: Grade A Clinicians should not recommend active surveillance for patients with high-risk localized prostate cancer. Moderate Recommendation; Evidence Level: Grade C Cryosurgery, focal therapy and HIFU treatments are not recommended for men with high-risk localized prostate cancer outside of a clinical trial.
Expert Opinion Clinicians should not recommend primary ADT for patients with high-risk localized prostate cancer unless the patient has both limited life expectancy and local symptoms. Strong Recommendation; Evidence Level: Grade Clinicians may consider referral for genetic counseling for patients and their families with high-risk localized prostate cancer and a strong family history of specific cancers e. Expert Opinion Recommended Approaches and Details of Specific Care Options Active Surveillance Localized prostate cancer patients who elect active surveillance should have accurate disease staging including systematic biopsy with ultrasound or MRI-guided imaging.
Clinical Principle Localized prostate cancer patients undergoing active surveillance should have routine surveillance PSA testing and digital rectal exams. Strong Recommendation; Evidence Level: Grade B Localized prostate cancer patients undergoing active surveillance should be encouraged to have a confirmatory biopsy within the initial two years and surveillance biopsies thereafter.
Clinical Principle Clinicians may consider multiparametric prostate MRI as a component of active surveillance for localized prostate cancer patients. Expert Opinion Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up. Expert Opinion Clinicians should offer definitive treatment to localized prostate cancer patients undergoing active surveillance who develop adverse reclassification.
Moderate Recommendation; Evidence Level: Grade B Prostatectomy Clinicians should inform localized prostate cancer patients that younger or healthier men e. Strong Recommendation; Evidence Level: Grade B Clinicians should inform localized prostate cancer patients that open and robot-assisted radical prostatectomy offer similar cancer control, continence recovery, and sexual recovery outcomes.
Strong Recommendation; Evidence Level: Grade B Clinicians should counsel localized prostate cancer patients that nerve-sparing is associated with better erectile function recovery than non-nerve sparing. Strong Recommendation; Evidence Level: Grade A Clinicians should not treat localized prostate cancer patients who have elected to undergo radical prostatectomy with neoadjuvant ADT or other systemic therapy outside of clinical trials.
Strong Recommendation; Evidence Level: Grade A Clinicians should inform localized prostate cancer patients considering prostatectomy, that older men experience higher rates of permanent erectile dysfunction and urinary incontinence after prostatectomy compared to younger men.
Strong Recommendation; Evidence Level: Grade B Pelvic lymphadenectomy can be considered for any localized prostate cancer patients undergoing radical prostatectomy and is recommended for those with unfavorable intermediate-risk or high-risk disease. Expert Opinion Clinicians should inform localized prostate cancer patients with unfavorable intermediate-risk or high-risk prostate cancer about benefits and risks related to the potential option of adjuvant radiotherapy when locally extensive prostate cancer is found at prostatectomy.
Moderate Recommendation; Evidence Level: Grade B Radiotherapy Clinicians may offer single modality external beam radiotherapy or brachytherapy for patients who elect radiotherapy for low-risk localized prostate cancer. Clinical Principle Clinicians may offer external beam radiotherapy or brachytherapy alone or in combination for favorable intermediate-risk localized prostate cancer. Clinical Principle Clinicians should offer months of ADT as an adjunct to either external beam radiotherapy alone or external beam radiotherapy combined with brachytherapy to patients electing radiotherapy for high-risk localized prostate cancer.
Strong Recommendation; Evidence Level: Grade A Clinicians should inform localized prostate cancer patients that use of ADT with radiation increases the likelihood and severity of adverse treatment-related events on sexual function in most men and can cause other systemic side effects. Strong Recommendation; Evidence Level: Grade B Clinicians should consider moderate hypofractionation when the localized prostate cancer patient of any risk category and clinician decide on external beam radiotherapy to the prostate without nodal radiotherapy.
Moderate Recommendation; Evidence Level: Grade B For localized prostate cancer patients with obstructive, non-cancer-related lower urinary function, surgical approaches may be preferred. Moderate Recommendation; Evidence Level: Grade C Clinicians should inform localized prostate cancer patients who are considering proton beam therapy that it offers no clinical advantage over other forms of definitive treatment. Moderate Recommendation; Evidence Level: Grade C Clinicians should inform localized prostate cancer patients considering brachytherapy that it has similar effects as external beam radiotherapy with regard to erectile dysfunction and proctitis but can also exacerbate urinary obstructive symptoms.
Expert Opinion Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery that cryosurgery has similar progression-free survival as did non-dose escalated external beam radiation also given with neoadjuvant hormonal therapy in low- and intermediate-risk disease, but conclusive comparison of cancer mortality is lacking. Conditional Recommendation; Evidence Level: Grade C Defects from prior transurethral resection of the prostate are a relative contraindication for whole gland cryosurgery due to the increased risk of urethral sloughing.
Clinical Principle For whole gland cryosurgery treatment, clinicians should utilize a third or higher generation, argon-based cryosurgical system for whole gland cryosurgery treatment. Clinical Principle Clinicians should inform localized prostate cancer patients considering cryosurgery that it is unclear whether or not concurrent ADT improves cancer control, though it can reduce prostate size to facilitate treatment.
Clinical Principle Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery that erectile dysfunction is an expected outcome.
Clinical Principle Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery about the adverse events of urinary incontinence, irritative and obstructive urinary problems. Moderate Recommendation; Evidence Level: Grade C As prostate cancer is often multifocal, clinicians should inform localized prostate cancer patients considering focal therapy that focal therapy may not be curative and that further treatment for prostate cancer may be necessary.
Expert Opinion Outcome Expectations and Management Treatment Side Effects and Health Related Quality of Life Clinicians should inform localized prostate cancer patients that erectile dysfunction occurs in many patients following prostatectomy or radiation, and that ejaculate will be lacking despite preserved ability to attain orgasm, whereas observation does not cause such sexual dysfunction.
Strong Recommendation; Evidence Level: Grade B Clinicians should inform localized prostate cancer patients that long-term obstructive or irritative urinary problems occur in a subset of patients following observation or active surveillance or following radiation, whereas prostatectomy can relieve pre-existing urinary obstruction. Strong Recommendation; Evidence Level: Grade B Clinicians should inform localized prostate cancer patients that temporary urinary incontinence occurs in most patients after prostatectomy and persists long-term in a small but significant subset, more than during observation or active surveillance or after radiation.
Strong Recommendation; Evidence Level: Grade A Clinicians should inform localized prostate cancer patients that temporary proctitis following radiation persists in some patients long-term in a small but significant subset and is rare during observation or active surveillance or after prostatectomy.
Clinical Principle Clinicians should inform localized prostate cancer patients of their individualized risk-based estimates of post-treatment prostate cancer recurrence. Clinical Principle Clinicians should support localized prostate cancer patients who have survivorship or outcomes concerns by facilitating symptom management and encouraging engagement with professional or community-based resources.
January Chapters available at www. National Comprehensive Cancer Network Iremashvili V, Pelaez L, Manoharan M et al: Pathologic prostate cancer characteristics in patients eligible for active surveillance: a head-to-head comparison of contemporary protocols. Zumsteg ZS, Spratt DE, Pei I et al: A new risk classification system for therapeutic decision making with intermediate-risk prostate cancer patients undergoing dose-escalated external-beam radiation therapy.
Prostate Cancer Prostatic Dis ; Epub ahead of print. Fowler FJ, Jr. Wennberg JE: Unwarranted variations in healthcare delivery: implications for academic medical centres. Cochrane Database Syst Rev. Violette PD, Agoritsas T, Alexander P et al: Decision aids for localized prostate cancer treatment choice: systematic review and meta-analysis. Institute of Medicine: Crossing the quality chasm: a new health system for the 21st century.
J Urol ; : Mitchell JM: Urologists use of intensity-modulated radiation therapy for prostate cancer. Fowler FJ Jr. Multidisciplinary care and management selection in prostate cancer. Semin Radiat Oncol ; 23 Gomella LG: Prostate cancer: the benefits of multidisciplinary prostate cancer care. Nat Rev Urol ; 9 Barocas DA, Alvarez J, Resnick MJ et al: Association between radiation therapy, surgery, or observation for localized prostate cancer and patient-reported outcomes after 3 years.
Chen RC, Basak R, Meyer AM et al: Association between radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance and patient-reported quality of life among men with localized prostate cancer.
J Urol ; Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. Nam RK, Cheung P, Herschorn S et al: Incidence of complications other than urinary incontinence or erectile dyscunction after radical prostatectomy or radiotherapy for prostate cancer: a population-based cohort study. Murray L, Henry A, Hoskin P et al: Second primary cancers after radiation for prostate cancer: a systematic review of the clinical data and impact of treatment technique.
American Urological Association: Ten things physicians and patients should question. Choosing Wisely Kibel AS, Ciezki JP, Klein EA et al: Survival among men with clinically localized prostate cancer treated with radical prostatectomy or radiation therapy in the prostate specific antigen era. Cooperberg MR, Vickers AJ, Broering JM et al: Comparative risk-adjusted mortality outcomes after primary surgery, radiotherapy, or androgen-deprivation therapy for localized prostate cancer.
Comparison of dose-escalated, image-guided radiotherapy vs. Am J Surg Pathol ; 36 Shappley WV 3rd, Kenfield SA, Kasperzyk JL et al: Prospective study of determinants and outcomes of deferred treatment or watchful waiting among men with prostate cancer in a nationwide cohort.
J Urol ; Epub ahead of print. San Francisco IF, Werner L, Regan MM et al: Risk stratification and validation of prostate specific antigen density as independent predictor of progression in men with low risk prostate cancer during active surveillance.
Bhindi B, Kulkarni GS, Finelli A et al: Obesity is associated with risk of progression for low-risk prostate cancers managed expectantly. Ploussard G, de la Taille A, Bayoud Y et al: The risk of upstaged disease increases with body mass index in low-risk prostate cancer patients eligible for active surveillance.
Urology ; Sundi, D, Ross AE, Humphreys EB et al: African American men with very low-risk prostate cancer exhibit adverse oncologic outcomes after radical prostatectomy: should active surveillance still be an option for them? Sammon JD, Abdollah F, Reznor G et al: Patterns of declining use and the adverse effect of primary androgen deprivation on all-cause mortality in elderly men with prostate cancer. Klein EA, Yousefi K, Haddad Z et al: A genomic classifier improves prediction of metastatic disease within 5 years after surgery in node-negative high-risk prostate cancer patients managed by radical prostatectomy without adjuvant therapy.
Radiation therapy uses high-energy rays or particles to kill cancer cells. Depending on the stage of the prostate cancer and other factors, radiation therapy might be used:. Another type of radiation therapy, in which a medicine containing radiation is injected into the body, is described in Treating Prostate Cancer Spread to the Bone. In EBRT , beams of radiation are focused on the prostate gland from a machine outside the body.
This type of radiation can be used to try to cure earlier stage cancers, or to help relieve symptoms such as bone pain if the cancer has spread to a specific area of bone. Each treatment is much like getting an x-ray. The radiation is stronger than that used for an x-ray, but the procedure typically is painless. Each treatment lasts only a few minutes, although the setup time — getting you into place for treatment — takes longer.
Newer EBRT techniques focus the radiation more precisely on the tumor. This lets doctors give higher doses of radiation to the tumor while reducing the radiation exposure to nearby healthy tissues. Radiation beams are then shaped and aimed at the prostate from several directions, which makes it less likely to damage surrounding normal tissues and organs.
It uses a computer-driven machine that moves around the patient as it delivers radiation. Along with shaping the beams and aiming them at the prostate from several angles, the intensity strength of the beams can be adjusted to limit the doses of radiation reaching nearby normal tissues.
This lets doctors deliver an even higher radiation dose to the cancer. Some newer radiation machines have imaging scanners built into them. This appears to help deliver the radiation even more precisely and results in fewer side effects.
It uses a machine that delivers radiation quickly as it rotates once around the body. This allows each treatment to be given over just a few minutes. This technique uses advanced image guided techniques to deliver large doses of radiation to a precise area, such as the prostate. Because there are large doses of radiation in each dose, the entire course of treatment is given over just a few days.
The side effects, though, are not better. Proton beam therapy focuses beams of protons instead of x-rays on the cancer. Unlike x-rays, which release energy both before and after they hit their target, protons cause little damage to tissues they pass through and release their energy only after traveling a certain distance.
This means that proton beam radiation can, in theory, deliver more radiation to the prostate while doing less damage to nearby normal tissues. Although in theory proton beam therapy might be more effective than using x-rays, so far studies have not shown if this is true. Right now, proton beam therapy is not widely available. Proton beam radiation might not be covered by all insurance companies at this time. Some of the side effects from EBRT are the same as those from surgery , while others are different.
Bowel problems: Radiation can irritate the rectum and cause a condition called radiation proctitis. This can lead to diarrhea , sometimes with blood in the stool, and rectal leakage. Most of these problems go away over time, but in rare cases normal bowel function does not return. To help lessen bowel problems, you may be told to follow a special diet during radiation therapy to help limit bowel movement during treatment.
Sometimes a balloon-like device is put in the rectum during each treatment to keep the bowel as still as possible while treatment is given. Urinary problems: Radiation can irritate the bladder and lead to a condition called radiation cystitis. Urinary problems usually improve over time, but in some men they never go away. As described in the surgery section, there are different levels and types of incontinence. Overall, this side effect occurs less often with radiation therapy than after surgery.
The risk is low at first, but it goes up each year for several years after treatment. Rarely, the tube that carries urine from the bladder out of the body the urethra may become very narrow or even close off, which is known as a urethral stricture. This might require further treatment to open it up again. Erection problems, including impotence: After a few years, the impotence rate after radiation is about the same as that after surgery.
Problems with erections usually do not occur right after radiation therapy but slowly develop over time. This is different from surgery, where impotence occurs immediately and may get better over time.
As with surgery, the older you are, the more likely it is you will have problems with erections. For more about coping with erection problems and other sexuality issues, see Sexuality for the Man With Cancer. Feeling tired: Radiation therapy can cause fatigue that might not go away until a few weeks or months after treatment stops.
Lymphedema: Lymph nodes normally provide a way for fluid to return to the heart from all areas of the body. If the lymph nodes around the prostate are damaged by radiation, fluid can collect in the legs or genital region over time, causing swelling and pain. Lymphedema can usually be treated with physical therapy, although it may not go away completely. See lymphedema to learn more. These pellets are placed directly into your prostate.
The use of brachytherapy is also limited by some other factors. For men who have had a transurethral resection of the prostate TURP or for those who already have urinary problems, the risk of urinary side effects may be higher. Brachytherapy might not work as well in men with large prostate glands because it might not be possible to place the seeds into all of the correct locations.
One way to get around this may be to get a few months of hormone therapy beforehand to shrink the prostate. Imaging tests such as transrectal ultrasound , CT scans , or MRI are used to help guide the placement of the radioactive pellets. Special computer programs calculate the exact dose of radiation needed. There are 2 types of prostate brachytherapy.
Both are done in an operating room. You will get either spinal anesthesia where the lower half of your body is numbed or general anesthesia where you are asleep , and you might need to stay in the hospital overnight.
Either brachytherapy treatment can be used alone or combined with external beam radiation given at a lower dose than if used by itself. In this type, pellets seeds of radioactive material such as iodine or palladium are placed inside thin needles, which are inserted through the skin in the area between the scrotum and anus and into the prostate.
The pellets are left in place as the needles are removed and give off low doses of radiation for weeks or months.
Radiation from the seeds travels a very short distance, so the seeds can give off a large amount of radiation in a very small area. This limits the amount of damage to nearby healthy tissues.
Usually, around seeds are placed, but this depends on the size of the prostate. Because the seeds are so small, they seldom cause discomfort, and are simply left in place after their radioactive material is used up. You may also get external beam radiation along with brachytherapy, especially if there is a higher risk that your cancer has spread outside the prostate for example, if you have a higher Gleason score. This technique is done less often. It leaves higher doses of radiation in place for a short time.
Hollow needles are placed through the skin between the scrotum and anus and into the prostate. Soft nylon tubes catheters are placed in these needles. The needles are then removed but the catheters stay in place. Radioactive iridium or cesium is then placed in the catheters, usually for 5 to 15 minutes. Generally, about 1 to 4 brief treatments are given over 2 days, and the radioactive substance is removed each time.
After the last treatment the catheters are removed. For about a week after treatment, you may have some pain or swelling in the area between your scrotum and rectum, and your urine may be reddish-brown. Radiation precautions: If you get permanent LDR brachytherapy, the seeds will give off small amounts of radiation for several weeks or months.
There's also a small risk that some of the seeds might move migrate. You may be asked to strain your urine for the first week or so to catch any seeds that might come out. You may be asked to take other precautions as well, such as wearing a condom during sex. Be sure to follow any instructions your doctor gives you. There have also been reports of the seeds moving through the bloodstream to other parts of the body, such as the lungs.
Bowel problems: Brachytherapy can sometimes irritate the rectum and cause a condition called radiation proctitis. Urinary problems: Severe urinary incontinence trouble controlling urine is not a common side effect.
But some men have problems with frequent urination or other symptoms due to irritation of the urethra, the tube that drains urine from the bladder. This tends to be worse in the weeks after treatment and gets better over time. Rarely, the urethra may actually close off known as a urethral stricture and need to be opened with a catheter or surgery. Erection problems: Some studies have found rates of erection problems to be lower after brachytherapy, but other studies have found that the rates were no different than with external beam radiation or surgery.
The younger you are and the better your sexual function before treatment, the more likely you will be to regain function after treatment. To learn more, see the Radiation Therapy section of our website.