Prophylactic Prostatectomy for Prostate Cancer (PPPC)

NCT06470685 | Enrolling By Invitation

• 1 other identifier: CCR5979
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prostatectomy

Outcome Measures

Primary Outcomes (1)

• What would be the uptake of prophylactic prostatectomy?

  To explore people's understandings, views and opinions on hypothetical prophylactic prostatectomy for those at high genetic risk of developing prostate cancer.

  Opinions collected and analysed over 12 months

Interventions

Qualitative Research Interviews BEHAVIORAL

Research Interviews

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will invite people aged 18 and over to take part in this research, including those at higher genetic risk based either on the result of a genetic test (including people who have a pathogenic variant in etihter the BRCA1 or BRCA2), people with a strong family history of prostate cancer, or of black ethnicity. We will include people who have not had any previous prostate surgery, and people who have had a prostatectomy as part of their cancer treatment. We aim to recruit from different socio-economic backgrounds and those of black ethnicity who are at higher-risk of developing prostate cancer. They will be recruited from RMH prostate cancer screening studies and from community organisations with links and expertise in working with under-served communities.

You may qualify if:

• People aged 18 and over.
• Unaffected people (ie no previous prostate surgery) assessed to be living at higher risk of prostate cancer based on either:
• Carrying a variant in a higher risk gene (eg BRCA2) AND/OR
• Having a strong family history of prostate cancer AND/OR
• Being of Black African or Black Caribbean ancestry
• AND/OR People who have undergone a prostatectomy for prostate cancer (as part of cancer treatment

You may not qualify if:

• \- People deemed unsuitable to approach by clinical team based on poor performance status or current concurrent medical condition.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: June 24, 2024
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)