- Describe your topic.
- Key Questions: 1. What is the optimal diagnostic strategy, or combination of diagnostic strategies to stage T3/T4 N0/N+ M0 Prostate Adenocarcinoma? a) Imaging (CT, MRI, PET, bone scan) b) Lymph node biopsy c) Laboratory biomarker (PSA) 2. For men with stage T3/T4 N0/N+ M0 Prostate Adenocarcinoma, what is the comparative effectiveness (benefits) of each treatment intervention, or any combination thereof, on oncological, functional, and quality of life/other patient reported outcomes? (look into timing, duration, dose, frequency) a) Radical prostatectomy ± cystectomy ± resection of the rectum ± lymph node dissection b) ADT c) Interstitial brachytherapy d) EBRT e) Cryotherapy f) HIFU g) Chemotherapy 3. For men with stage T3/T4 N0/N+ M0 Prostate Adenocarcinoma receiving any type of combination of treatment interventions, what are the types of short- and long-term complications (harms) associated with these intervention? Population of interest: Adult males aged ≥18 years with non-metastatic clinical and pathologic T3/T4 prostate adenocarcinoma • Who may or may not have clinically suspicious pelvic lymph nodes • And, who are considering primary therapy only (previously untreated/ non-recurrent disease) Interventions: 1. Diagnostic and Staging Interventions a) MRI, CT and PET (choline, gallium, sodium fluoride, PSMA) scans of the abdomen and pelvis b) Bone scan c) Lymph node biopsy 2. Treatment Interventions a) Surgical intervention • Radical prostatectomy (open, robot-assisted, laparoscopic) ± cystectomy ± resection of the rectum (aka exenteration) • Lymph node dissection b) Non-surgical intervention • Androgen Deprivation Therapy (ADT) • Interstitial Brachytherapy (low dose rate and high dose rate) • External Beam Radiation Therapy (EBRT) • Cryotherapy • High Intensity Focused Ultrasound (HIFU) • Chemotherapy Comparison: 1. Diagnostic and Staging Interventions a) MRI vs. CT of the abdomen and pelvis (± contrast) b) PET (choline vs. gallium vs. sodium fluoride vs. PSMA) scans of the abdomen and pelvis c) MRI vs. CT vs. PET scans of the abdomen and pelvis d) Staging CT vs. bone scan e) LN biopsy alone vs. with any combination of the above pelvic imaging techniques f) Any other comparative studies examining diagnostic/staging interventions 2. Treatment Interventions a) Surgical intervention • Open vs. robot-assisted vs. laparoscopic radical prostatectomy ± cystectomy ± resection of the rectum • Radical prostatectomy vs radiation therapy • Radical prostatectomy + standard lymph node dissection vs Radical prostatectomy + extended lymph node dissection b) Non-Surgical Intervention (neoadjuvant and adjuvant) • Neoadjuvant ADT vs. placebo • Adjuvant ADT (initiated within the first year post-radical prostatectomy and in the absence of biochemical recurrence) vs. placebo • External Beam Radiation Therapy (EBRT) with Intensity-modulated radiation therapy (IMRT) boost vs EBRT with Low-dose radiation brachytherapy boost • EBRT vs. placebo • Any combination of radiotherapy ± ADT • Any combination of chemotherapy ± radiotherapy ± ADT • Cryotherapy ± ADT • HIFU ± ADT c) Surgical intervention alone vs. any type or combination of non-surgical intervention alone. Outcomes: Diagnostic interventions: • Sensitivity and Specificity of diagnostic tests to diagnose and stage T3/T4 disease and/or lymph node metastasis Therapeutic interventions: • Overall survival • Cancer-specific survival • Progression-free survival/Metastatic-free survival • PSA biochemical recurrence • Quality of Life and other Patient Reported Outcomes • Short- and long-term morbidity associated with surgical procedures • Short- and long-term morbidity associated with any of the non-surgical interventions (bone health status with ADT, pathological fractures, sexual dysfunction, anemia, psychological and cognitive effects, cardiovascular morbidity, secondary malignancies, infections, etc) Exclusions: • Metastatic disease (outside the pelvic lymph nodes); positive bone scan • Variant histology: Non-adenocarcinomas of the prostate, Small cell carcinomas of the prostate, Sarcoma of the prostate • Metastasis to the prostate • Patients with recurrent disease, or receiving salvage therapy for documented recurrence • Patients who have T1 and T2 prostate cancer
- Describe why this topic is important.
- Prostate cancer is the most common non-skin cancer and a leading cause of cancer death among American men of all races.1 Urologists have been and should remain the primary champions of this disease. The management of locally advanced prostate cancer has become increasingly complex with more treatment options available, and sprouting evidence of the potential importance of multi-modal treatment. In addition, there is conflicting evidence of both, over-utilization and under-utilization of appropriate imaging to stage locally advanced disease prior to treatment assignment. This highlights the increasing importance of implementing high quality evidence synthesis to guide the development of recommendations focused on understanding the benefits and harms of each modality and approach, as well as with encouraging integrated care across providers and modalities. 1 U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2014 Incidence and Mortality Web-based Report. Atlanta: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention and National Cancer Institute; 2017. Available at: www.cdc.gov/uscs.
- Tell us why you are suggesting this topic.
- Locally advanced prostate cancer is defined by tumors that has breached the prostate capsule and has extended beyond the prostate gland. Cancer cells may have spread to the seminal vesicles (T3), or to adjacent structures such as the urethral sphincter, rectum, bladder, and/or the wall of the pelvis [T4], including possible extension into the loco-regional pelvic lymph nodes (N+). Locally advanced prostate cancer however is not associated with the presence of any distant metastases. The proposed evidence report would help identify recommended practices for the staging and management of treatment-naïve locally advanced prostate cancer, defined as T3/T4 N0/N+ M0 disease after weighing in the benefits and harms associated with each strategy or approach. [1] https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/staging.html
- Target Date.
- 2018-05-15
- Describe what you are doing currently and what you are hoping will change because of a new evidence report.
- The AUA currently has four guidelines that cover topics related to prostate cancer: a) Early Detection of Prostate Cancer (updated in 2015) which covers PSA screening practices b) Clinically Localized Prostate Cancer (2017) which focuses on the diagnosis and management of T1/T2 disease c) Radiation after Prostatectomy (2013) which focuses on the appropriate use of adjuvant or salvage radiotherapy in radiation-naïve men who have undergone radical prostatectomy d) Castration-Resistant Prostate Cancer (Updated in 2015) which focuses on men with non-metastatic as well as metastatic disease who have continually rising PSA despite medical or surgical castration. The AHRQ-produced locally advanced prostate cancer evidence report would help support the mission of AUA to develop high quality, evidence-based guidance focusing on a segment of the prostate cancer population which has yet to be addressed in any of the AUA Prostate Cancer guideline series. The development of a clinical practice guideline on locally advanced prostate cancer would subsequently enable the AUA to develop additional material with a strong focus on the importance of patient counseling and education, which is essential for a condition that relies heavily on shared decision making when discussing treatment options.
- How will you or your group use the information from a new evidence report?
- The AUA intends to use this systematic report developed by AHRQ as the basis for an evidence-based guideline. The creation of an evidence report on this topic would allow the AUA to create a clinical practice guideline in a relatively short timeframe as the data collection, extraction and analysis would have already been completed in adherence with the highest standards of systematic review. AUA guidelines are scientifically rigorous and evidence-based, and with a staff of six full-time professionals as well as extensive consultant support, the AUA Guidelines Department is well positioned to develop high-quality guidelines in a timely, efficient and effective manner.
- How would you or your group plan to disseminate information from the report? Who would you plan to disseminate it to?
- The AUA continues its dedication to providing quality, evidence-based education through the dissemination of pocket guides and other educational products to both urologic specialists and primary care physicians who most commonly treat the patients described herein. Additionally, the AUA Guidelines Department works closely with the Urology Care Foundation, committed to patient education and advocacy, to develop patient guides from its clinical practice guidelines.
- Do you know of organizations that could use an evidence report to change clinical practice? Are you a part of, or have you been in contact with, any organizations that might implement the research findings of an evidence report?
- 1. American Urological Association (AUA) 2. Urology Care Foundation 3. European Association of Urology (EAU) 4. Canadian Urological Association (CUA) 5. American Society for Radiation Oncology (ASTRO) 6. Society of Urologic Oncology (SUO)
- Information About You: (optional)
-
- Provide a description of your role or perspective.
- Director of Guideline
- If you are you making a suggestion on behalf of an organization, please state the name of the organization.
- American Urological Association
- Please tell us how you heard about the Effective Health Care Program.
