Prostate cancer - Clinically localized Flashcards
What is shared decision making
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.(Strong Recommendation; Evidence Level: Grade A)
- Prostate cancer patients should be counseled regarding the importance of modifiable health-related behaviors or risk factors, such as smoking and obesity. (Expert Opinion)
- 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.(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. (Expert Opinion)
Care options fo low/ very low risk group
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.(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. (Moderate Recommendation; Evidence Level: Grade B)
- 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.(Conditional Recommendation; Evidence Level: Grade B)
- Clinicians should not add androgen deprivation therapy (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. (Expert Opinion)
- Clinicians should recommend observation or watchful waiting for men with a life expectancy ≤5 years with lowrisk localized prostate cancer. (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)
Care options - 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 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 come with a higher risk of developing metastases compared to definitive treatment. (Conditional Recommendation; Evidence Level: Grade C)
- Clinicians should recommend observation or watchful waiting for men with a life expectancy ≤5 years with intermediate-risk localized prostate cancer. (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. (Expert Opinion)
Care options - High Risk Disease
- Clinicians should stage high-risk localized prostate cancer patients with cross sectional imaging (CT or MRI) and bone scan. (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. Watchful waiting should only be considered in asymptomatic men with limited life expectancy ≤ 5 years). (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 A)
- 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). (Expert Opinion
Details of Active Surveillance
- Localized prostate cancer patients who elect active surveillance should have accurate disease staging including systematic biopsy with ultrasound or MRIguided 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)
Details of Prostatectomy
- 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. (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. (Moderate Recommendation; Evidence Level: Grade C)
- Clinicians should inform localized prostate cancer patients that robotic/laparoscopic or perineal techniques are associated with less blood loss than retropupic prostatectomy. (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. Patients should be counseled regarding the common complications of lymphadenectomy, including lymphocele development and its treatment. (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)
Details of 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 24-36 months of ADT as an adjunct to either external beam radiotherapy alone or external beam radiotherapy combined with brachytherapy to patients electing radiotherapy for highrisk 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. If radiotherapy is used for these patients or those with previous significant transurethral resection of the prostate, low-dose rate brachytherapy should be discouraged. (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)
Whole Gland Cryotherapy - Details
- 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. (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. (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. (Strong Recommendation; Evidence Level: Grade B)
HIFU and Focal Therapy details
Clinicians should inform those localized prostate cancer patients considering focal therapy or HIFU that these treatment options lack robust evidence of efficacy. (Expert Opinion)
- Clinicians should inform localized prostate cancer patients who are considering HIFU that even though HIFU is approved by the FDA for the destruction of prostate tissue, it is not approved explicitly for the treatment of prostate cancer. (Expert Opinion)
- 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. (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 HRQOL
Clinicians should inform those localized prostate cancer patients considering focal therapy or HIFU that these treatment options lack robust evidence of efficacy. (Expert Opinion)
- Clinicians should inform localized prostate cancer patients who are considering HIFU that even though HIFU is approved by the FDA for the destruction of prostate tissue, it is not approved explicitly for the treatment of prostate cancer. (Expert Opinion)
- 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. (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)
Post-Treatment Followup
- 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. (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. (Clinical Principle)
Risk stratification for localized prostate cancer
Level of evidence for individual treatment options
Radiation after prostatectomy
Patients who are being considered for management of localized prostate cancer with radical prostatectomy should be informed of the potential for adverse pathologic findings that portend a higher risk of cancer recurrence and that these findings may suggest a potential benefit of additional therapy after surgery. (Clinical Principle)
- Patients with adverse pathologic findings including seminal vesicle invasion, positive surgical margins, and extraprostatic extension should be informed that adjuvant radiotherapy, compared to radical prostatectomy only, reduces the risk of biochemical (PSA) recurrence, local recurrence, and clinical progression of cancer. They should also be informed that the impact of adjuvant radiotherapy on subsequent metastases and overall survival is less clear; one of two randomized controlled trials that addressed these outcomes indicated a benefit but the other trial did not demonstrate a benefit. However, the other trial was not powered to test the benefit regarding metastases and overall survival. (Clinical Principle)
- Physicians should offer adjuvant radiotherapy to patients with adverse pathologic findings at prostatectomy including seminal vesicle invasion, positive surgical margins, or extraprostatic extension because of demonstrated reductions in biochemical recurrence, local recurrence, and clinical progression. (Standard; Evidence Strength: Grade A)
- Patients should be informed that the development of a PSA recurrence after surgery is associated with a higher risk of development of metastatic prostate cancer or death from the disease. Congruent with this clinical principle, physicians should regularly monitor PSA after radical prostatectomy to enable early administration of salvage therapies if appropriate. (Clinical Principle)
- Clinicians should define biochemical recurrence as a detectable or rising PSA value after surgery that is ≥ 0.2 ng/ml with a second confirmatory level ≥ 0.2 ng/ml. (Recommendation; Evidence Strength: Grade C)
- A restaging evaluation in the patient with a PSA recurrence may be considered. (Option; Evidence Strength: Grade C)
- Physicians should offer salvage radiotherapy to patients with PSA or local recurrence after radical prostatectomy in whom there is no evidence of distant metastatic disease. (Recommendation; Evidence Strength: Grade C)
- Patients should be informed that the effectiveness of radiotherapy for PSA recurrence is greatest when given at lower levels of PSA. (Clinical Principle)
- Patients should be informed of the possible short-term and long-term urinary, bowel, and sexual side effects of radiotherapy as well as of the potential benefits of controlling disease recurrence. (Clinical Principle)