Clinical trial · Interventional
The Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS)
The Prostate Cancer, Genetic Risk, and Equitable Screening Study (ProGRESS): A Pragmatic Trial of Precision Prostate Cancer Screening
- 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)
Prostate cancer is the most common non-skin cancer among Veterans and the second leading cause of male cancer death. Current methods of screening men for prostate cancer are inaccurate and cannot identify which men do not have prostate cancer or have low-grade cases that will not cause harm and which men have significant prostate cancer needing treatment. False-positive screening tests can result in unnecessary prostate biopsies for men who do not need them. However, new genetic testing might help identify which men are at highest risk for prostate cancer. This study will examine whether a genetic test helps identify men at risk for significant prostate cancer while helping men who are at low risk for prostate cancer avoid unnecessary biopsies. If this genetic test proves beneficial, it will improve the way that healthcare providers screen male Veterans for prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Precision screening intervention | Genetic | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Precision screening intervention
- description
- The precision screening intervention will consist of an interpreted prostate cancer genetic risk assessment (GRA) report, provided to the participant along with tailored prostate cancer screening recommendations and, in cases of high genetic risk, genetic counseling. The risk report and supporting educational materials will also be provided to the participant's primary care provider. Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.
- interventionNames
- Genetic: Precision screening intervention
- Other: Usual care
- type
- EXPERIMENTAL
- label
- Usual care
- description
- Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.
- interventionNames
- Other: Usual care
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 55 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * baseline age 55-69 years * receipt of regular VA care * Veteran status Exclusion Criteria: * personal history of prostate cancer * prior prostate biopsy, prostatectomy, or prostate MRI * known carrier status of rare variant associated with cancer syndrome
References
Publications (2)
- DERIVEDGriffin JN, Danowski ME, Gerety HL, Lafferty K, Clayman ML, Antwi AA, Bertero MG, Brunette CA, Gillespie C, Guentert L, Lennon NJ, Martin J, Patel LS, Vassy JL. Development and pilot testing of a prostate cancer polygenic risk report. BMC Med Genomics. 2026 Jul 30;19(1):137. doi: 10.1186/s12920-026-02416-4. PMID 42661205
- DERIVEDVassy JL, Dornisch AM, Karunamuni R, Gatzen M, Kachulis CJ, Lennon NJ, Brunette CA, Danowski ME, Hauger RL, Garraway IP, Kibel AS, Lee KM, Lynch JA, Maxwell KN, Ratner D, Rose BS, Teerlink CC, Xu GJ, Hofherr SE, Lafferty KA, Larkin K, Malolepsza E, Patterson CJ, Toledo DM, Donovan JL, Hamdy FC, Martin RM, Neal DE, Turner EL, Andreassen OA, Dale AM, Mills IG, Abraham A, Batra J, Clements J, Cussenot O, Cybulski C, Eeles RA, Fowke JH, Grindedal EM, Gronberg H, Hamilton RJ, Lim J, Lu YJ, MacInnis RJ, Maier C, Mucci LA, Multigner L, Neuhausen SL, Nielsen SF, Parent ME, Park JY, Petrovics G, Plym A, Razack A, Rosenstein BS, Schleutker J, Sorensen KD, Townsend PA, Travis RC, Vega A, West CML, Wiklund F, Zheng W; Profile Steering Committee; IMPACT Study Steering Committee and Collaborators; PRACTICAL Consortium; VA Million Veteran Program; Seibert TM. Genomic risk model to implement precision prostate cancer screening in clinical care: the ProGRESS study. Nat Cancer. 2026 Feb;7(2):352-367. doi: 10.1038/s43018-025-01103-0. Epub 2026 Jan 26. PMID 41588240