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NCT06470685Enrolling by invitation

Prophylactic Prostatectomy for Prostate Cancer (PPPC)

Assessing the Acceptability of Prophylactic Prostatectomy for People At High Genetic Risk of Developing Prostate Cancer: a Qualitative Study

Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
20 (estimated)
First submitted
17 Jun 2024
Start date
24 Jun 2024
Primary completion date
24 Jun 2025
Lead sponsor
Royal Marsden NHS Foundation Trust
NCT number
NCT06470685

What you commit to

  • Study type: Observational
  • Planned participants: 20
  • From 24 Jun 2024 to the primary completion date, 24 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The Royal Marsden NHS Foundation Trust
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LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.