BJU international
June 9, 2026 · via Europe PMC
The 'Prostate Cancer Screening for People at Genetic Risk of Aggressive Disease' (PATROL) study.
Cheng HH, Maxwell KN, Salari K, +9 more, Lin DW.
AI summary — for doctors, generated from the abstract only
This is a study protocol (not yet reporting results) describing a multicenter study that will test whether age-adjusted PSA thresholds and prostate MRI can accurately identify clinically significant prostate cancer in men carrying inherited genetic mutations that raise their prostate cancer risk.
What was studied
The PATROL study protocol describes a multicenter, prospective study enrolling individuals aged 40 and older who carry an inherited genetic mutation (such as BRCA2, HOXB13, ATM, BRCA1, MSH2, MSH6, CHEK2, or TP53) known to increase prostate cancer risk, aiming to determine the positive predictive value of age-adjusted PSA thresholds and prostate MRI for detecting clinically significant prostate cancer through annual screening and biopsy when indicated.
Key findings
- This is a protocol description, so no results are yet available
- Planned study procedures include annual physical exam and PSA testing, with optional or recommended MRI depending on PSA level, and biopsy offered based on age-specific PSA thresholds or clinical concern
- Participants diagnosed with prostate cancer who choose active surveillance will be followed with study procedures annually for 10 years or until definitive treatment
Clinical relevance
Not applicable yet, since this is a protocol describing a planned study rather than reporting outcomes; if successful, this study could help refine prostate cancer screening recommendations specifically for men with inherited high-risk genetic mutations.
Who should care
Limitations
As a study protocol, no results, including diagnostic accuracy or clinical outcome data, are available yet; findings will depend on the study's eventual completion and reported results.
A new multicenter study will test whether age-adjusted PSA thresholds and MRI can effectively screen for prostate cancer in men with inherited high-risk genetic mutations, but results are not yet available since this report only describes the planned study design.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Background
Inherited (germline) pathogenic and likely pathogenic variants (gPVs) in key genes associated with increased risk of prostate cancer (PCa) now warrant more attentive PCa screening per National Comprehensive Cancer Network (NCCN) guidelines-e.g., BRCA2, HOXB13, ATM, BRCA1, MSH2, MSH6, CHEK2 and TP53. However, the optimal early detection strategy for gPV carriers, including use of age-adjusted PSA thresholds and prostate imaging may be refined. and as a means to investigate novel biomarkers.
Study design
'Prostate Cancer Screening for People at Genetic Risk of Aggressive Disease' (PATROL) is a multicentre, prospective early detection study for individuals at increased risk for PCa due to carrying a gPV in a PCa risk gene.
Endpoints
The primary endpoint is to determine the positive predictive value of pre-defined age-directed prostate-specific antigen (PSA) level thresholds and prostate-specific imaging, e.g., multiparametric magnetic resonance imaging (MRI) for clinically significant PCa on biopsy for individuals at risk of PCa due to a gPV. Exploratory endpoints include characterising clinicopathological characteristics of PCa and patient-reported outcomes. Biospecimens will be collected to evaluate emerging clinical and research biomarkers.
Patients and methods
Key eligibility includes: individuals aged ≥40 years who carry a gPV in an eligible gene, who have no prior diagnosis of PCa, do not have another active malignancy, and provide informed consent. Study procedures include annual physical examination and PSA. Imaging with MRI is optional at baseline and recommended if the PSA level is above the protocol-recommended PSA level threshold. Participants will be offered prostate biopsy for any clinical concern, PSA level >1.0 ng/mL if aged 1.5 ng/mL if aged 50-59 years; PSA level >2.0 ng/mL if aged ≥60 years. If PCa is diagnosed, clinical care is determined by the participant and treating physician. If opting for active surveillance, study procedures will be collected annually for 10 years or until definitive treatment. If definitive treatment, study procedures will be collected for an additional 1 year. Long-term clinical outcomes will be collected annually until the study closes.
DOI
10.1111/bju.70334
PMID
42265755
PMCID
PMC13550811
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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