Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03805919

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer.

Objectives:

To study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer.

Eligibility:

Males between ages 30-75 who have one or more specific genetic changes but without prostate cancer.

Design:

  • This study does not perform genetic testing. All participants must have documented genetic changes and able to provide a copy of the report.
  • Before enrollment, participants will provide a copy of documented genetic changes and go through a telephone interview to determine eligibility for the study.
  • On enrollment, participants will have medical and family history review, medication review, physical exam, blood collection for clinical and research testing, and MRI (magnetic resonance imaging) of the prostate.
  • Every year, participants will repeat the physical exam, medical history, family history, medication review, routine blood tests, including PSA and testosterone.
  • Every 2 years, participants will repeat all the above plus prostate MRI and blood tests for research.
  • If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be asked to do a biopsy.
  • If the biopsy results in prostate cancer, participants will be given counseling on next steps, general treatment recommendations, and then followed with a phone call each year.
  • Participants may ask to speak with a genetic counselor.

Conditions

Prostatic Neoplasms

Study ID

NCT03805919

Start date

Mar 27, 2019

Status verified date

Sep 1, 2026

Completion date

Jan 1, 2039

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 30 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort 1

Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes

Primary outcome measure

  • Natural history of high genetic risk for prostate cancer [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Anna C Couvillon, C.R.N.P.

(240) 858-3148couvilla@mail.nih.gov

Fatima H Karzai, M.D.

(301) 480-7174fatima.karzai@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 3, 2026

Last verified

Sep 1, 2026

Keywords

  • BRCA 1
  • BRCA 2
  • MMR genes
  • Lynch Syndrome
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-03.