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Men at High Genetic Risk for Prostate Cancer

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Official record

Identifier
NCT03805919
Recruiting locations

country

United States
Interventions studied
Not provided in the official record
Lead sponsor
National Cancer Institute (NCI)
Target enrolment
500 participants
Study type
OBSERVATIONAL
Phase
Not provided in the official record
Status
Recruiting
First posted
Jan 16, 2019
Last updated on the registry
Sep 3, 2026
Age
30 Years – 75 Years
Sex
MALE
Study contact
The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

* Inclusion Criteria:
* Males between ages 30-75 years old.
* Documented germline variant (i.e. pathogenic/likely pathogenic variant) in prostate cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).
* Prognosis of \>5 years survival if affected by another cancer
* Ability of subject to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior diagnosis or treatment for prostate cancer
* Known contraindication to MRI:

  * Participants unable to fit through MRI scanner (radiologist discretion)
  * Allergy to MR contrast agent
  * Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic device
* Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.
Indexed under
Colorectal Cancer