Long-term observational study to understand the genetic profiles of prostate cancer patients over time

• Your participation will continue for life as part of our effort to gather comprehensive data on the progression of prostate cancer. This includes tracking disease recurrence, response to therapies, and the duration of these responses.
• We will collect detailed clinical information throughout the study, including updates from medical history, clinical tests, imaging studies, surgical reports, and any new genetic test results.
• Our goal is to maintain active contact with you, adjusting our understanding of prostate cancer based on long-term observations of your health outcomes.

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• Diagnosis: You must have prostate cancer confirmed through medical testing, and be 18 years or older in age
• Genetic Requirements: You need to have certain genetic changes known as variants. These can be in any of the following genes: PIK3, AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, and genes involved in the Wnt/B-catenin pathway, CDK12, and MMR (MLH1, MSH2, MSH6, PMS2, EPCAM). You might also qualify if you have a high tumor mutational burden (TMB-high) or if you've responded exceptionally well to previous treatments. This study is looking for participants who meet these specific genetic criteria because they may respond differently to potential treatments.

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This study requires a longer term commitment:

‍Study Commitment:

• This is a long-term, multi-center study focusing on understanding prostate cancer more deeply. You will not be required to visit the National Institutes of Health (NIH) regularly, unless you are already participating in another NIH study.
• If you do visit NIH for any reason, we may collect blood, urine, and any leftover tumor samples to study your genes.
• Whether or not you are regularly at NIH, you will be contacted every six months via phone or email to update your health information and review your medical records.

Testing During the Study:

• You will undergo regular tests for testosterone levels and prostate-specific antigen (PSA) to monitor your health.
• Occasionally, you may be invited to provide additional blood samples for research purposes at NIH.

Long-term Follow-Up:

• Your participation will continue for life as part of our effort to gather comprehensive data on the progression of prostate cancer. This includes tracking disease recurrence, response to therapies, and the duration of these responses.
• We will collect detailed clinical information throughout the study, including updates from medical history, clinical tests, imaging studies, surgical reports, and any new genetic test results.
• Our goal is to maintain active contact with you, adjusting our understanding of prostate cancer based on long-term observations of your health outcomes.

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California Locations

La Jolla, California, United States, 92093

• Recruiting: University of California San Diego
• Contact: Audrey Dinh, 858-657-7516, ahdinh@health.ucsd.edu

San Francisco, California, United States, 94143

• Recruiting: University of California San Francisco
• Contact: Kaitlin Zablotsky, 415-502-5775, kaitlin.Zablotsky@ucsf.edu

Maryland Locations

Bethesda, Maryland, United States, 20892

• Recruiting: National Institutes of Health Clinical Center
• Contact: Fatima Karzai, M.D., 301-480-7174, fatima.karzai@nih.gov

Massachusetts Locations

Boston, Massachusetts, United States, 02114

• Not yet recruiting: Massachusetts General Hospital, Cancer Center
• Contact: Xin Gao, 617-724-4000, XGAO4@partners.org

Boston, Massachusetts, United States, 02215

• Recruiting: Dana Farber Cancer Institute, Boston, MA
• Contact: Dory Freeman, 617-632-2389, DoryA_Freeman@DFCI.HARVARD.EDU

Michigan Locations

Ann Arbor, Michigan, United States, 48109

• Not yet recruiting: University of Michigan
• Contact: Arul Chinnaiyan, 734-647-8903, arul@med.umich.edu

New York Locations

New York, New York, United States, 10007

• Recruiting: Memorial Sloan Kettering Cancer Center
• Contact: Ashley Regazzi, 646-888-1359, regazzia@mskcc.org

New York, New York, United States, 10029

• Not yet recruiting: Mount Sinai Hospital
• Contact: William Oh, 212-241-6756, William.Oh@mssm.edu

New York, New York, United States, 10065

• Not yet recruiting: Weill Cornell Medicine
• Contact: Cora Sternberg, 646-962-2072, cns9006@med.cornell.edu

Oregon Locations

Portland, Oregon, United States, 97239

• Not yet recruiting: Oregon Health Sciences University
• Contact: Julie Graff, 503-494-6594, graffj@ohsu.edu

Washington Locations

Seattle, Washington, United States, 28104

• Not yet recruiting: Fred Hutchinson Cancer Center
• Contact: Kamilah Taylor, 206-598-0860, kit2@uw.edu

Seattle, Washington, United States, 98195

• Not yet recruiting: Seattle Cancer Care Alliance
• Contact: Kamilah Taylor, 206-598-0860, kit2@uw.edu

Seattle, Washington, United States, 98195

• Not yet recruiting: University of Washington
• Contact: Kamilah Taylor, 206-598-0860, kit2@uw.edu

Spain

Barcelona, Spain, 08035

• Not yet recruiting: Vall d'Hebron Institute of Oncology
• Contact: Joaquin Mateo, (932) -54-3450, jmateo@vhio.net

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Screening and Enrollment:

• At the start, your medical records and any available genetic test results will be reviewed to confirm eligibility.
• You will be interviewed either over the phone or in person to gather additional health information.

‍Importance of Your Participation:

• By being part of this study, you contribute to a better understanding of prostate cancer, which can lead to improved treatment strategies and outcomes for future patients. Your long-term health and responses to treatment provide invaluable data that help researchers piece together the complex nature of prostate cancer.

This study is designed to be minimally disruptive to your regular medical care while providing vital data that can influence the future of prostate cancer treatment and research.

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