NCT05129605Recruiting
Prostate Cancer Genetic Risk Evaluation and Screening Study
Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
Source: ClinicalTrials.gov · Last updated 9 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 2 Nov 2021
- Start date
- 12 Feb 2020
- Primary completion date
- Dec 2030
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT05129605
What you commit to
- Study type: Observational
- Planned participants: 400
- From 12 Feb 2020 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis or treatment of prostate cancer
Other
- Inability to undergo prostate MRI
- Inability to receive MRI contrast agent
Who the study is looking for
- 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
Age in the registry: 35 years to 74 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.