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    Clinically Localized Prostate Cancer (beta)

    Based on guidelines from AUA, ASTRO, and SUO, also endorsed by ASCO.

    Strength
    Strong recommendation
    Moderate recommendation
    Conditional recommendation
    N/A
    Evidence
    Grade A quality evidence
    Grade B quality evidence
    Grade C quality evidence
    Clinical principle
    Expert opinion

    Shared Decision Making

    Shared Decision Making
    1. Counseling of patients to select a management strategy for localized prostate cancer should incorporate shared decision making and explicitly consider cancer severity (risk category), patient values and preferences, life expectancy, pre-treatment general functional and genitourinary symptoms, expected post-treatment functional status, and potential for salvage treatment.
    2. Prostate cancer patients should be counseled regarding the importance of modifiable health-related behaviors or risk factors, such as smoking and obesity.
    3. Clinicians should encourage patients to meet with different prostate cancer care specialists (e.g. urology and either radiation oncology or medical oncology or both), when possible to promote informed decision making.
    4. 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.
    5. Clinicians should inform patients about suitable clinical trials and encourage patients to consider participation in such trials based on eligibility and access.

    Management

    Very Low-/Low-risk Disease
    1. Clinicians should not perform abdomino-pelvic CT or routine bone scans in the staging of asymptomatic very low- or low-risk localized prostate cancer patients.
    2. Clinicians should recommend active surveillance as the best available care option for very low-risk localized prostate cancer patients.
    3. Clinicians should recommend active surveillance as the preferable care option for most low-risk localized prostate cancer patients.
    4. Clinicians may offer definitive treatment (i.e., radical prostatectomy or radiotherapy) to select low-risk localized prostate cancer patients who may have a high probability of progression on active surveillance.
    5. Clinicians should not add androgen deprivation therapy along with radiotherapy for low-risk localized prostate cancer with the exception of reducing the size of the prostate for brachytherapy.
    6. 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.
    7. Clinicians should inform low-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound that these interventions are not standard care options because comparative outcome evidence is lacking.
    8. Clinicians should recommend observation or watchful waiting for men with a life expectancy ≤5 years with low-risk localized prostate cancer.
    9. 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.
    Intermediate-risk Disease
    1. Clinicians should consider staging unfavorable intermediate-risk localized prostate cancer patients with cross sectional imaging (CT or MRI) and bone scan.
    2. Clinicians should recommend radical prostatectomy or radiotherapy plus androgen deprivation therapy as standard treatment options for patients with intermediate-risk localized prostate cancer.
    3. 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 androgen deprivation therapy.
    4. 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.
    5. Clinicians should recommend observation or watchful waiting for men with a life expectancy ≤5 years with intermediate-risk localized prostate cancer.
    6. Clinicians should inform intermediate-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound that these interventions are not standard care options because comparative outcome evidence is lacking.
    High-risk Disease
    1. Clinicians should stage high-risk localized prostate cancer patients with cross sectional imaging (CT or MRI) and bone scan.
    2. Clinicians should recommend radical prostatectomy or radiotherapy plus androgen deprivation therapy as standard treatment options for patients with high-risk localized prostate cancer.
    3. Clinicians should not recommend active surveillance for patients with high-risk localized prostate cancer. Watchful waiting should only be considered in asymptomatic men with limited life expectancy (≤5 years).
    4. Cryosurgery, focal therapy, and high intensity focused ultrasound treatments are not recommended for men with high-risk localized prostate cancer outside of a clinical trial.
    5. Clinicians should not recommend primary androgen deprivation therapy for patients with high-risk localized prostate cancer unless the patient has both limited life expectancy and local symptoms.
    6. 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.g. breast, ovarian, pancreatic, other gastrointestinal tumors, lymphoma).

    Treatment

    Active Surveillance
    1. Localized prostate cancer patients who elect active surveillance should have accurate disease staging including systematic biopsy with ultrasound or MRI-guided imaging.
    2. Localized prostate cancer patients undergoing active surveillance should have routine surveillance PSA testing and digital rectal exams.
    3. Localized prostate cancer patients undergoing active surveillance should be encouraged to have a confirmatory biopsy within the initial two years and surveillance biopsies thereafter.
    4. Clinicians may consider multiparametric prostate MRI as a component of active surveillance for localized prostate cancer patients.
    5. Tissue based genomic biomarkers have not shown a clear role in active surveillance for localized prostate cancer and are not necessary for follow up.
    6. Clinicians should offer definitive treatment to localized prostate cancer patients undergoing active surveillance who develop adverse reclassification.
    Prostatectomy
    1. Clinicians should inform localized prostate cancer patients that younger or healthier men (e.g. <65 years of age or >10 year life expectancy) are more likely to experience cancer control benefits from prostatectomy than older men.
    2. Clinicians should inform localized prostate cancer patients that open and robot-assisted radical prostatectomy offer similar cancer control, continence recovery, and sexual recovery outcomes.
    3. Clinicians should inform localized prostate cancer patients that robotic/laparoscopic or perineal techniques are associated with less blood loss than retropupic prostatectomy.
    4. Clinicians should counsel localized prostate cancer patients that nerve-sparing is associated with better erectile function recovery than non-nerve sparing.
    5. Clinicians should not treat localized prostate cancer patients who have elected to undergo radical prostatectomy with neoadjuvant androgen deprivation therapy or other systemic therapy outside of clinical trials.
    6. 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.
    7. 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.
    8. 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.
    Radiotherapy
    1. Clinicians may offer single modality external beam radiotherapy or brachytherapy for patients who elect radiotherapy for low-risk localized prostate cancer.
    2. Clinicians may offer external beam radiotherapy or brachytherapy alone or in combination for favorable intermediate-risk localized prostate cancer.
    3. Clinicians should offer 24-36 months of androgen deprivation therapy 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.
    4. Clinicians should inform localized prostate cancer patients that use of androgen deprivation therapy 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.
    5. 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).
    6. 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.
    7. 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.
    8. 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.
    Whole Gland Cryosurgery
    1. Clinicians may consider whole gland cryosurgery in low- and intermediate-risk localized prostate cancer patients who are not suitable for either radical prostatectomy or radiotherapy due to comorbidities yet have >10 year life expectancy.
    2. Defects from prior transurethral resection of the prostate are a relative contraindication for whole gland cryosurgery due to the increased risk of urethral sloughing.
    3. For whole gland cryosurgery treatment, clinicians should utilize a third or higher generation, argon-based cryosurgical system for whole gland cryosurgery treatment.
    4. Clinicians should inform localized prostate cancer patients considering cryosurgery that it is unclear whether or not concurrent androgen deprivation therapy improves cancer control, though it can reduce prostate size to facilitate treatment.
    5. Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery that erectile dysfunction is an expected outcome.
    6. Clinicians should inform localized prostate cancer patients considering whole gland cryosurgery about the adverse events of urinary incontinence, irritative and obstructive urinary problems.
    High Intensity Focused Ultrasound and Focal Therapy
    1. Clinicians should inform those localized prostate cancer patients considering focal therapy or high intensity focused ultrasound that these treatment options lack robust evidence of efficacy.
    2. Clinicians should inform localized prostate cancer patients who are considering high intensity focused ultrasound that even though high intensity focused ultrasound is approved by the U.S. Food and Drug Administration for the destruction of prostate tissue, it is not approved explicitly for the treatment of prostate cancer.
    3. Clinicians should advise localized prostate cancer patients considering high intensity focused ultrasound that tumor location may influence oncologic outcome. Limiting apical treatment to minimize morbidity increases the risk of cancer persistence.
    4. 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.

    Outcome Expectations and Management

    Treatment Side Effects and Health Related Quality of Life
    1. 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.
    2. 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.
    3. Clinicians should inform localized prostate cancer patients that whole-gland cryosurgery is associated with worse sexual side effects and similar urinary and bowel/rectal side effects as those after radiotherapy.
    4. 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.
    5. 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.
    Post-treatment Follow Up
    1. Clinicians should monitor localized prostate cancer patients post therapy with prostate specific antigen, even though not all prostate specific antigen recurrences are associated with metastatic disease and prostate cancer specific death.
    2. Clinicians should inform localized prostate cancer patients of their individualized risk-based estimates of post-treatment prostate cancer recurrence.
    3. 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.
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    Research PaperBekelman JE, Rumble RB, Chen RC, et al. Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology Guideline. J Clin Oncol. 2018;:JCO1800606.