Evaluating genetic risk and screening for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on men at high genetic risk for prostate cancer due to specific genetic mutations, family history, or Black/African ancestry. It aims to assess the effectiveness of prostate MRI as a screening tool to enable early detection of aggressive prostate cancer. By collecting clinical data and biospecimens from participants, the study seeks to understand the penetrance of genetic mutations and potentially identify new risk factors. Participants will undergo prostate exams, PSA tests, and MRIs to characterize cancer-related outcomes associated with their genetic profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Individuals with a prostate aged 35 years or older
* No known diagnosis of prostate cancer
* Life expectancy \>10 years
* Meet cohort A, B, or C criteria
* Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
* Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
* Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Exclusion Criteria:

* Prior diagnosis or treatment of prostate cancer
* Inability to undergo prostate MRI
* Inability to receive MRI contrast agent

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Keyan Salari, MD, PhD — Massachusetts General Hospital
• Study coordinator: Olympia Price
• Email: oprice@partners.org
• Phone: 857-238-3838

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.