Prophylactic Prostatectomy for Prostate Cancer (PPPC)
NCT06470685 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-03-27
Summary
Prostate cancer affects 1-in-8 people assigned male at birth in the UK and kills almost 12,000 annually. Half the cases occur due to genetic factors. These include rare highly-penetrant mutations such as BRCA2 as well as a combination of common genetic variants. A 'polygenic risk score' can be used to identify people who may develop more aggressive forms of the disease. Prophylactic, or 'risk-reducing' mastectomy and oophorectomy has been shown to prevent mortality and be acceptable for healthy women with known genetic risks. There is no such evidence as yet of the benefits of similar surgery for people at a higher genetic risk of developing prostate cancer. However, this question is often posed in clinic by people who carry pathogenic variants in BRCA2. In the future we propose to develop a feasibility study offering prophylactic prostatectomy to people based on their high genetic risk.
Prior to this, we wish to undertake this pilot qualitative study to better understand patients' perspectives on the acceptability of the procedure. Prostatectomy carries risks, with potential impact on erectile function and urinary continence. In this year-long project we will conduct up to 20 semi-structured interviews with patients and public to explore acceptability and to identify informational and support needs envisaged by men contemplating prophylactic prostatectomy. We will invite people aged over 18 to take part. We will include a wide range of perspectives including those at higher genetic risk or a strong family history of prostate cancer, as well as those with unknown or normal genetic risk factors. We will include people from different socio-economic backgrounds and those of black ethnicity who carry a higher risk. They will be recruited from existing prostate cancer screening studies and from community organisations with expertise in working with under-served communities.
Conditions
- Prostate Cancer
- Genetic Predisposition to Disease
- BRCA Mutation
Interventions
- BEHAVIORAL
-
Qualitative Research Interviews
Research Interviews
Sponsors & Collaborators
-
Institute of Cancer Research, United Kingdom
collaborator OTHER -
Royal Marsden NHS Foundation Trust
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-06-24
- Primary Completion
- 2025-06-24
- Completion
- 2025-06-24
Countries
- United Kingdom
Study Locations
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