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

  • Not Yet Recruiting
  • Diagnostic
  • Interventional
  • Non Randomized
  • Diagnostic Test
  • Heinrich-Heine University, Duesseldorf
  • 18 Years -

Study Purpose

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.

Intervention

Diagnostic Test : Panel sequencing, whole exome sequencing, whole genome sequencing

Eligibility Requirements

info icon 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)

info icon healthy men with genetic risk (BRCA1/2 Germline mutation)

info icon 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)

info icon \<18 years

info icon no consent

Recruiting status

Not Yet Recruiting

Estimated enrollment

300

 
Study start date

Feb 01, 2023

Study end date

Feb 01, 2027

Last updated

Mar 22, 2025

Primary purpose

Diagnostic

Design

Interventional

Intervention

Diagnostic Test

Study phase

NA

Allocation

Non Randomized

 

Sponsor:

Heinrich-Heine University, Duesseldorf

Collaborator:

German Cancer Aid

Investigator:

Peter Albers

Dagmar Wieczorek

N/A

Publications

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Mohler JL, Antonarakis ES, Armstrong AJ, D'Amico AV, Davis BJ, Dorff T, Eastham JA, Enke CA, Farrington TA, Higano CS, Horwitz EM, Hurwitz M, Ippolito JE, Kane CJ, Kuettel MR, Lang JM, McKenney J, Netto G, Penson DF, Plimack ER, Pow-Sang JM, Pugh TJ, Richey S, Roach M, Rosenfeld S, Schaeffer E, Shabsigh A, Small EJ, Spratt DE, Srinivas S, Tward J, Shead DA, Freedman-Cass DA. Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 May 1;17(5):479-505. doi: 10.6004/jnccn.2019.0023.

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Websites

N/A

NCT05681416

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