-
Diagnosing, Staging, and Treating Locally Advanced Prostate Cancer
- Supporting Document: [[{"fid":"18584","view_mode":"default","fields":{"class":"media-element file-default cke_widget_element","data-delta":"1","format":"default","alignment":"","field_doc_file_type[und][0][value]":"PDF"},"type":"media","field_deltas":{"1":{"class":"media-element file-default cke_widget_element","data-delta":"1","format":"default","alignment":"","field_doc_file_type[und][0][value]":"PDF"}},"link_text":"Download Topic Nomination Key Questions and PICOTS","attributes":{"class":"media-element file-default","data-delta":"1"}}]]
- Describe your topic.
- KEY QUESTIONS: KQ1: What is the optimal strategy or combination of strategies to diagnose and stage locally advanced prostate cancer? a. Imaging (CT, MRI, PET, bone scan) b. Lymph node biopsy c. PSA/biomarkers POPULATION: Men with suspected prostate cancer INTERVENTIONS: Imaging (CT, MRI, PET, bone scan), lymph node biopsy, PSA/biomarkers COMPARISONS: Each diagnostic modality against all others; no imaging; no biopsy; no PSA; variations in dose (when appropriate), phase (when appropriate), use of contrast (when appropriate) OUTCOMES: Sensitivity, specificity, likelihood ratio, diagnostic odds ratio TIMING: Any duration of testing/follow up SETTING: Inpatient or outpatient KQ2A: What is the comparative effectiveness of the following treatment options (alone or in combination) in terms of oncological outcomes, and adverse effects (harms)/quality of life/other patient-reported outcomes for the treatment of men diagnosed with locally advanced prostate cancer? a. Hormonal therapy b. Radiotherapy (brachytherapy, EBRT, IMRT, SBRT, 3D-CRT, proton) c. Chemotherapy d. Surgery (radical prostatectomy, cystectomy, resection of the rectum, lymph node dissection) e. HIFU f. Cryotherapy KQ2B: How do specific patient characteristics (e.g., age, race/ethnicity, presence or absence of comorbid conditions) affect the outcomes of these therapies overall and differentially? KQ2C: How do tumor characteristics (e.g., Gleason score/Grade group, tumor volume/stage, PSA levels) affect the outcomes of these therapies overall and differentially? POPULATION: Men with a diagnosis of locally advanced prostate cancer (T3-T4, N0/N+, M0) INTERVENTIONS: Hormonal therapy, radiotherapy (brachytherapy, EBRT, IMRT, SBRT, 3D-CRT, proton), chemotherapy, surgery (radical prostatectomy, cystectomy, resection of the rectum, lymph node dissection), HIFU, cryotherapy COMPARISONS: Each intervention against all others; variations in timing, duration, dose, frequency, technique OUTCOMES: Overall survival, progression-free survival, metastasis-free survival, short- and long-term morbidity (e.g., bone health, sexual dysfunction, anemia, psychological and cognitive effects, cardiovascular morbidity, secondary malignancies, infections), biochemical recurrence, quality of life/patient-reported outcomes TIMING: Any duration of treatment/follow up SETTING: Inpatient or outpatient KQ3: What is the comparative effectiveness of survivorship surveillance protocols for men who elected treatment following a diagnosis of locally advanced prostate cancer? POPULATION: Men who completed treatment for locally advanced prostate cancer (T3-T4, N0/N+, M0) INTERVENTIONS: Imaging (CT, MRI, PET, bone scan), PSA/biomarkers, Physical exam COMPARISONS: No protocol (usual care) or other survivorship surveillance protocols; variations in dose (when appropriate), phase (when appropriate), use of contrast (when appropriate), timing, frequency OUTCOMES: Overall survival, progression-free survival, metastasis-free survival, short- and long-term morbidity (e.g., bone health, sexual dysfunction, anemia, psychological and cognitive effects, cardiovascular morbidity, secondary malignancies, infections), biochemical recurrence, quality of life/patient-reported outcomes TIMING: Any duration of follow up SETTING: Inpatient or outpatient
- Describe why this topic is important.
- Prostate cancer is among the most commonly diagnosed malignancies in men, accounting for an estimated 1 in 5 diagnoses for 2018. Additionally, prostate cancer is one of the top causes of cancer-related death in men with nearly 30,000 of 160,000 men diagnosed in the US succumbing to the disease in 2018.[1] African American men are nearly twice as likely to die from prostate cancer compared to men of Caucasian descent.[2] While prostate cancer may be curable when detected at an early stage, one analysis of SEER data through 2012 indicates a potential increase in the number of diagnoses of distant stage prostate cancer among men aged 50 to 69 years following a recent decline in prostate cancer screening.[3] Once prostate cancer reaches more advanced stages, it becomes an incurable disease with treatments affecting survival only modestly. Locally advanced prostate cancer is defined as disease that has extended beyond the prostatic capsule based on clinical or radiographic assessment. This may include locoregional lymph node invasion, but no distant metastases. Roughly 10% of men diagnosed with prostate cancer will be found to have locally advanced disease.[4] This patient population is highly heterogeneous, with many men successfully undergoing local definitive therapy, while others require systemic therapy to achieve acceptable longer-term cancer control.[5] As such, it is important to be able to recognize those patients who may be at higher risk for recurrence or progression to more extensive disease states. There is a great need for high-quality guidance in this space given that there is little consensus available on the appropriate means to diagnose and stage prostate cancer. Further, while it is highly encouraging that there are now a number of treatment options available for men once diagnosed, physicians are faced with a multitude of treatment options that are each associated with specific benefits and harms for a given patient. While there is now more research supporting the use of multimodal therapy in such men, many patients still elect monotherapy. Studies have suggested that many men with clinically significant disease are undertreated, often due to poor staging and inappropriate choice of therapy.[6] At a population level, little is known about patient choice of cancer therapy and the factors leading to such patient decisions.[7] A guidance document such as that which would be developed from the proposed systematic review nomination would offer physicians a source of evidence-based guidance to aid in the selection of appropriate diagnostic and treatment mechanisms, ultimately resulting in the betterment of patient care. While there is sparse guidance available in this space, the rapidly progressing nature of the research for locally advanced prostate cancer necessitates an update of such material in order to provide the most relevant and accurate data available. Furthermore, AUA guidelines have been recognized for their outstanding methodological rigor, which ensures that the systematic review developed from this nomination will help to create a document of the highest quality. Once developed, this guideline will undergo regular review to ensure that the content is always up to date in keeping with the latest advances in the field of cancer research. Finally, all AUA guidelines are used in the development of associated patient materials through the Urology Care Foundation, which strives to support urologic research and provide the most current, comprehensive and reliable urologic health information for patients and the public. REFERENCES 1. Siegel RL, Miller KD, Jemal A: Cancer statistics, 2018. CA Cancer J Clin 2018; 68: 7. 2. American Cancer Society: Cancer facts & figures for African Americans 2016-2018. Atlanta: American Cancer Society 2016. 3. Hoffman RM, Meisner AL, Arap W et al: Trends in United States prostate cancer incidence rates by age and stage, 1995-2012. Cancer Epidemiol Biomarkers Prev; 2016: 25: 259. 4. Amiya Y, Yamada Y, Sugiura M et al: Treatment of locally advanced prostate cancer (Stage T3). Jpn J Clin Oncol 2017; 47: 257. 5. Khan PA and Partin AW: Management of high-risk populations with locally advanced prostate cancer. Oncologist 2003; 8: 259. 6. Hounsome, L, Rowe E, Verne J et al: Variation in usage of radical prostatectomy and radical radiotherapy for men with locally advanced prostate cancer. J Clin Urol 2017; 10: 34. 7. Lowrance WT, Elkin EB, Yee DS et al: Locally advanced prostate cancer: a population-based study of treatment patterns. BJU Int 2012; 109: 1309.
- Tell us why you are suggesting this topic.
- The AUA guideline that will be produced from the proposed evidence report has the potential to standardize evaluation and treatment algorithms, decrease the substantial cost associated with the diagnosis and treatment of locally advanced prostate cancer, and provide guidance regarding the numerous available treatment options. There is a lack of guidance documents in this disease space, and such a guideline could have a tremendous impact on both clinical outcomes and patient satisfaction. While the influx of a tremendous amount of new research in this disease space is promising, it also creates the issue of providing physicians with a multitude of treatment options with specific risk/benefit profiles for each patient. The proposed guideline would provide such physicians with recommendations for patient treatment supported by high-quality clinical data analyzed by a team of experts using the highest standards of methodological rigor.
- Target Date.
- Describe what you are doing currently and what you are hoping will change because of a new evidence report.
- AUA maintains a number of guidelines in the prostate cancer space, including Early Detection of Prostate Cancer, Clinically Localized Prostate Cancer, Adjuvant and Salvage Radiotherapy after Prostatectomy, and Castration-Resistant Prostate Cancer (CRPC). In addition, a guideline is currently in production on Advanced Prostate Cancer. Through the proposed evidence report, AUA will fill a clear gap with the development of a guideline on Locally Advanced Prostate Cancer. This is a disease space where men have a number of treatment options, each associated with various benefits and harms. As such, it is critical that physicians who treat these patients are able to do so with the support of the most currently available high-quality data. Prior to the release of the AUA guideline on CRPC, membership surveys showed that a number of physicians treating such patients were not using any guidance document to do so. Following the publication of the CRPC guideline, surveys show that over 95% of the membership now utilizes the AUA guideline as a reference document when treating such patients. With an ever-growing focus on patient reported outcomes and quality of life, it is essential that physicians possess a document developed using the highest standards of methodological rigor to educate patients about their treatment options and engage in a shared-decision making process when choosing a treatment. Through the use of such documents, we hope to improve both clinical and quality of life outcomes for men seeking care for locally advanced prostate cancer.
- 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 guideline produced from the proposed evidence report would be available on the AUA website, available to both AUA members and non-members. AUA also has various marketing plans in place to directly disseminate the guideline information to the over 22,000 AUA members as well as other interested stakeholders. 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 other physicians who most commonly treat the patients described herein. An executive summary of the guideline would be published in the Journal of Urology, and presentations would be given at AUA Annual and Section meetings through both plenary presentations and education-based courses. Further, 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. The development of a clinical practice guideline on Locally Advanced Prostate Cancer would enable the AUA to develop additional material with a strong focus on the importance of patient counseling and education, which is essential for the treatment of a disease that relies heavily on shared decision making when discussing treatment options. Additional dissemination channels would also be explored through any collaborating partners as part of the guideline development process.
- 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?
- Treatment of prostate cancer (at any stage) involves a multi-disciplinary approach that includes a number of specialists addressing specific aspects of patient care. As such, AUA plans to produce a guideline inclusive of such specialties as has been done previously with other AUA/AHRQ-developed evidence reports, including Localized Prostate Cancer, Non-Muscle Invasive Bladder Cancer, and Non-Metastatic Muscle-Invasive Bladder Cancer. Through a multi-specialty collaborative effort supported by AUA, the guideline produced from the proposed AHRQ report will be developed by a team of specialists including representation from urology, oncology, radiation oncology, and patient advocacy. AUA also works through the Urology Care Foundation to develop and disseminate information on all AUA guideline topics to patients and patient advocacy organizations.
- Information About You: (optional)
-
- Provide a description of your role or perspective.
- Professional Society
- 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.
- The AUA has previously partnered with AHRQ in the development of a number of evidence reports.
