NCT05681416: ProFam-Risk

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

Not yet recruiting NA Last updated 12 January 2023

What this trial tests

NA trial testing Panel sequencing, whole exome sequencing, whole genome sequencing in Prostate Cancer in 300 participants. Not yet recruiting.

Timeline

1 February 2023

Primary endpoint
1 February 2026

1 February 2027

Quick facts

Lead sponsor	Heinrich-Heine University, Duesseldorf
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	300
Start date	1 February 2023
Primary completion	1 February 2026
Estimated completion	1 February 2027

Drugs / interventions tested

• Panel sequencing, whole exome sequencing, whole genome sequencing

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →
• Familial Prostate Cancer — all drugs for Familial Prostate Cancer →

Sponsor

Heinrich-Heine University, Duesseldorf

Who can join

18 and older, male only, with Prostate Cancer or Familial Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Psychosocial outcomes of risk-adapted prevention for prostate cancer predisposition: study protocol for a longitudinal observational mixed-methods study.
   Klett MK, Albers P, Lakes J, Niegisch G, et al · · 2025 · cited 2× · PMID 40685233 · DOI 10.1136/bmjopen-2025-103679
2. Genetic Testing and Imaging in Men with Familial History or Genetic Predisposition of Prostate Cancer-Introducing the Prospective "ProFam-Risk" Study.
   Lakes J, Boschheidgen M, Antoch G, Klett MK, et al · · 2026 · PMID 41561489 · DOI 10.1016/j.euros.2025.12.018