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The Active Surveillance Study

NCT05810467 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-02-04

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • North Bristol NHS Trust

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Ros A Eeles, FRCP, FRFR · Institute of Cancer Research and Royal Marsden Hospital

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-22
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810467 on ClinicalTrials.gov