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NCT05681416Not yet recruiting

Prostate Cancer Prevention Clinic for Men With Risk of Familial Prostate Cancer

Source: ClinicalTrials.gov · Last updated 12 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Secondary prevention of prostate cancer (PCa) is not standardized and high-risk groups at the time of diagnosis are not well defined. Hereditary susceptibility which is reported in about 10% of men is one important risk factor for PCa development but the absolute risk and clinical importance is fairly unknown. The population risk for developing PCa is estimated to be 11%. If men carry a mutation in BRCA2 or HOXB13, the lifetime risk is 2 to 10-fold increased. "ProFam-Risk" is a prospective cohort analysis not only to validate the known genetic risk scores but also to establish recommendations for follow of high risk populations based on a combination of clinical parameters, imaging (magnetic resonance imaging of the prostate), and genetic profile. Aim of this individualized recommendation is on the one hand to early detect PCa before developing of advanced disease and on the other hand to counsel men at low risk in order to prevent overdiagnosis and overtreatment. Overall, "ProFam-Risk" aims to create a best possible counseling and clinical care for men with familial risk to develop PCa. In this pilot study, about 100 men per year will be included for a total period of 3 years. In addition to the registration of clinical, imaging, and genetic information, liquids and tissue (if available) will be sampled for analysis in the above mentioned research questions.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
300 (estimated)
First submitted
29 Nov 2022
Start date
1 Feb 2023
Primary completion date
1 Feb 2026
Lead sponsor
Heinrich-Heine University, Duesseldorf
NCT number
NCT05681416

What you commit to

  • Study type: Interventional
  • Planned participants: 300
  • From 1 Feb 2023 to the primary completion date, 1 Feb 2026
  • No sites listed in no 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.

Age

  • \<18 years

Other

  • no consent

Who the study is looking for

  • Healthy men with familial risk ( ≥ 2 first-degree relatives with PCA diagnosed at any age oder ≥ 1 first-degree relative with PCA diagnosed at the age \<60)
  • healthy men with genetic risk (BRCA1/2 Germline mutation)
  • Men with PCA and genetic oder familial risk (familial risk = ≥ 2 first-degree relatives with PCA diagnosed at any age oder ≥ 1 first-degree relative with PCA diagnosed at the age \<60; genetic risk= BRCA1/2 Germline mutation)

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

Full criteria on ClinicalTrials.gov

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