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RECRUITING
NCT05810467

The Active Surveillance Study

Sponsor: Institute of Cancer Research, United Kingdom

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2023-08-22

Completion Date

2027-12

Last Updated

2026-02-04

Healthy Volunteers

No

Conditions

Interventions

OTHER

Active 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.

Locations (4)

Institute of Cancer Research and Royal Marsden Hospital

Sutton, Surrey, United Kingdom

North Bristol NHS Trust

Bristol, United Kingdom

The Royal Marsden Hospital

London, United Kingdom

The Royal Marsden Hospital

Sutton, United Kingdom