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

Summary

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.

Conditions

• Prostate Cancer
• Familial Prostate Cancer

Interventions

DIAGNOSTIC_TEST

Panel sequencing, whole exome sequencing, whole genome sequencing

Besides the mutation positive men (group 2), all will receive multigene panel analysis in a patient care setting and if negative, whole exome sequencing (WES), whole genome sequencing and transcriptome analyses. In PCA-affected men (group 3), additional mutational analysis will be performed on formalin-fixed paraffin embedded (FFPE) - and fresh frozen (FF) tumor tissue from biobanked radical prostatectomy specimens using FFPE panel analysis (like TruSightOncology 500) or WES if FF samples are available.

Sponsors & Collaborators

• German Cancer Aid

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Peter Albers · Department of Urology, University of Dusseldorf, Germany

• Dagmar Wieczorek · Humangenetics, University of Dusseldorf, Germany

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-01

Primary Completion

2026-02-01

Completion

2027-02-01