Evaluating genetic risk and screening for prostate cancer
Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
This study is testing if prostate MRIs can help men at high genetic risk for prostate cancer find aggressive forms of the disease earlier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 35 Years to 74 Years |
| Sex | Male |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05129605 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men aged 35-74 with specific genetic mutations, a strong family history of prostate cancer, or those of Black/African ancestry.
Not a fit: Patients with a prior diagnosis of prostate cancer or those unable to undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of aggressive prostate cancer in high-risk populations.
How similar studies have performed: Other studies have shown success in using genetic risk factors to guide prostate cancer screening, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.