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Search / Trial NCT05129605

Prostate Cancer Genetic Risk Evaluation and Screening Study

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 9, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Brca2 Brca1 Mismatch Repair Deficiency Lynch Syndrome Hoxb13 Family History Of Prostate Cancer

ClinConnect Summary

The Prostate Cancer Genetic Risk Evaluation and Screening Study is looking to understand how men who are at high genetic risk for prostate cancer can be better identified and monitored. This includes men with specific genetic mutations, those with a strong family history of prostate cancer, and Black men with African ancestry. The study is also testing whether using MRI scans can help find prostate cancer earlier and more accurately in these high-risk groups. The researchers believe that these men may have a higher chance of developing aggressive types of prostate cancer compared to others.

To be eligible for this study, participants must be men aged 35 to 74 who do not currently have prostate cancer and are expected to live for at least another 10 years. They must either have a documented genetic mutation linked to prostate cancer, have a strong family history of the disease, or identify as Black American or Black Caribbean with African ancestry. Participants will undergo MRI scans to help screen for prostate cancer, which is a safe and non-invasive procedure. This study aims to improve early detection and better understand the genetic factors that contribute to prostate cancer risk.

Gender

MALE

Eligibility criteria

  • 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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Keyan Salari, MD, PhD

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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