NCT05926102

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
53mo left

Started Feb 2024

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Feb 2024Sep 2030

First Submitted

Initial submission to the registry

June 21, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2030

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

June 21, 2023

Last Update Submit

January 9, 2026

Conditions

Prostate Cancer

Keywords

early detection of cancerprostatic neoplasmspolygenic risk scoresfamily health history

Outcome Measures

Primary Outcomes (2)

  • Diagnosis of clinically significant prostate cancer

    Cases of csPCa will be abstracted from VA and survey data and defined using NCCN classifications of intermediate risk or higher: PSA 10 and/or Grade Group 2 and/or clinical T stage T2b

    7 years

  • Negative prostate biopsy

    Counts of negative prostate biopsies not temporally associated with csPCa (within 6 months of diagnosis) will be abstracted from VA and survey data

    7 years

Secondary Outcomes (6)

  • Diagnosis of prostate cancer

    7 years

  • Prostate biopsy

    7 years

  • PSA testing

    7 years

  • Prostate MRI

    7 years

  • Self-rated health

    7 years

  • +1 more secondary outcomes

Other Outcomes (3)

  • Adherence to precision cancer screening recommendations

    7 years

  • Acceptability of the precision prostate cancer screening intervention

    7 years

  • Rare pathogenic/likely pathogenic variants

    7 years

Study Arms (2)

Precision screening intervention

EXPERIMENTAL

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.

Genetic: Precision screening interventionOther: Usual care

Usual care

EXPERIMENTAL

Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.

Other: Usual care

Interventions

Precision screening interventionGENETIC

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.

Precision screening intervention
Usual careOTHER

Usual care in this study includes receipt of a brief brochure about shared decision-making in prostate cancer screening.

Precision screening interventionUsual care

Eligibility Criteria

Age55 Years - 69 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • baseline age 55-69 years
  • receipt of regular VA care
  • Veteran status

You may not qualify if:

  • personal history of prostate cancer
  • prior prostate biopsy, prostatectomy, or prostate MRI
  • known carrier status of rare variant associated with cancer syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

RECRUITING

Related Publications (1)

  • Vassy 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: 41588240DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsGenetic Risk Score

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesGenetic Predisposition to DiseaseDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jason L Vassy, MD MPH

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles A Brunette, PhD

CONTACT

(857) 364-6324charles.brunette@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Enrolled participants will be randomly allocated to receive either the precision screening intervention or usual care. 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2023

First Posted

July 3, 2023

Study Start

February 1, 2024

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2030

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Individual participant data will be stored in a data repository available for request by approved individuals.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Access Criteria
Requestors may be required to have IRB approval, data use agreements, and other regulatory and administrative credentials and authorizations prior to receiving data.

Locations

US(1)