NCT05129605 Prostate Cancer Genetic Risk Evaluation and Screening Study
| NCT ID | NCT05129605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Prostatic Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-02-12 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2020-02-12 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Keyan Salari, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05129605 clinical trial?
This trial is open to male participants only, aged 35 Years or older, up to 74 Years, studying Prostatic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05129605 currently recruiting?
Yes, NCT05129605 is actively recruiting participants. Contact the research team at oprice@partners.org for enrollment information.
Where is the NCT05129605 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05129605 clinical trial?
NCT05129605 is sponsored by Massachusetts General Hospital. The principal investigator is Keyan Salari, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 400 participants.