Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05129605

Conditions

Prostatic Neoplasm

Prostate Cancer

BRCA2 Mutation

BRCA1 Mutation

ATM Gene Mutation

Eligibility Criteria

Sex: Male

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Prostate cancer screening

Study Details

Brief summary:

This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.

Conditions

Prostatic Neoplasm

Prostate Cancer

BRCA2 Mutation

BRCA1 Mutation

ATM Gene Mutation

Study ID

NCT05129605

Start date

Feb 12, 2020

Status verified date

Oct, 2024

Completion date

Dec, 2040

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 35 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men 35-74 years old
  • 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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort A

Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene

Cohort B

Family history suggestive of high genetic risk for prostate cancer with clinical genetic testing negative for known pathogenic or likely pathogenic mutations in prostate cancer-related risk genes

Cohort C

Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry

Interventions

Prostate cancer screening

Physical exam (digital rectal exam), prostate-specific antigen (PSA) and PSA derivatives, and multiparametric MRI of the prostate

Primary outcome measure

  • Diagnosis of prostate cancer [ Time Frame: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first ]

Central Contacts and Locations

Central contacts

Olympia Price

857-238-3838oprice@partners.org

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Keywords

  • BRCA2
  • BRCA1
  • Mismatch Repair Deficiency
  • Lynch Syndrome
  • HOXB13
  • Family History of Prostate Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2024-10-09.