Clinical trial · Observational
Prostate Cancer Genetic Risk Evaluation and Screening Study
Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ATM Gene Mutation | — | UNRESOLVED | — |
| BRCA1 Mutation | — | UNRESOLVED | — |
| BRCA2 Mutation | — | UNRESOLVED | — |
| Genetic Predisposition to Disease | — | UNRESOLVED | — |
| Lynch Syndrome | — | UNRESOLVED | — |
| MMR Mutation | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate cancer screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- Documented germline known pathogenic or likely pathogenic mutation in a prostate cancer related risk gene
- interventionNames
- Diagnostic Test: Prostate cancer screening
- label
- Cohort B
- description
- 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
- interventionNames
- Diagnostic Test: Prostate cancer screening
- label
- Cohort C
- description
- Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
- interventionNames
- Diagnostic Test: Prostate cancer screening
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDAmini AE, Salari K. Incorporating Genetic Risk Into Prostate Cancer Care: Implications for Early Detection and Precision Oncology. JCO Precis Oncol. 2024 Feb;8:e2300560. doi: 10.1200/PO.23.00560. PMID 38412389
- RESULTAmini AE, Hunter AE, Almashad A, Feng AJ, Patel ND, O'Dea MR, McCormick SR, Rodgers LH, Salari K. Magnetic Resonance Imaging-based Prostate Cancer Screening in Carriers of Pathogenic Germline Mutations: Interim Results from the Initial Screening Round of the Prostate Cancer Genetic Risk Evaluation and Screening Study. Eur Urol Oncol. 2024 Dec;7(6):1358-1366. doi: 10.1016/j.euo.2024.01.015. Epub 2024 Mar 6. PMID 38453598