RecruitingNCT05810467

The Active Surveillance Study

Active Surveillance Study for Prostate Cancer Management for Men at Higher Genetic Risk Compared With Men at No Known Higher Genetic Risk.

Sponsor

Institute of Cancer Research, United Kingdom

Enrollment

200 participants

Start Date

Aug 22, 2023

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer

Summary

The Active Surveillance study is a prospective study developed to look at the association of biomarkers with PrCa presentation and progression among men on Active Surveillance and stratify it by their genetic risk. This study will also investigate the incidence and progression by differing genetic risks.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following men with low-risk prostate cancer who have chosen active surveillance — meaning they are being closely monitored rather than immediately treated — and includes men at higher genetic risk for prostate cancer due to family history or inherited gene mutations. **You may be eligible if...** - You are a man aged 18 or older currently in an active surveillance program for prostate cancer - Your cancer has been deemed appropriate for active surveillance by your medical team - You have a family history of prostate cancer (a first- or second-degree relative diagnosed under 70), OR - You carry a genetic mutation that increases prostate cancer risk (e.g., BRCA2, BRCA1, HOXB13, ATM, or CHEK2) **You may NOT be eligible if...** - You are already receiving active treatment (surgery, radiation, or hormones) for prostate cancer - You are not enrolled in an active surveillance clinic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERActive Surveillance

Active surveillance (AS) is an accepted management strategy for men diagnosed with low risk PrCa, generally defined as PSA \<10ng/ml and Gleason score of ≤6 and clinical stage T1 to T2a. Occasionally, a minority of men with Gleason 3+4 disease are included, though majority of those included in AS studies have Gleason 3+3 disease or less. Men in AS studies have repeated biopsies based on various criteria including PSA velocity, repeat biopsy at set time points and change noted on digital rectal examination (DRE), biopsy or MRI imaging. Progression of disease has been defined in various ways in different studies, generally, using criteria of Gleason upgrade to greater than Gleason 3+3, evidence of Gleason 4 or Gleason 5 disease, \>50% involvement of any one biopsy core, and greater than 2 cores positive on repeat biopsy. Percentages of men on AS who have upgrade on repeat biopsy have been found to be 19-34%; this may differ in our cohort of men with increased genetic risk for PrCa.