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NCT05810467Recruiting

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.

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
21 Mar 2023
Start date
22 Aug 2023
Primary completion date
Dec 2027
Lead sponsor
Institute of Cancer Research, United Kingdom
NCT number
NCT05810467

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 22 Aug 2023 to the primary completion date, Dec 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any significant psychological conditions that may be worsened or exacerbated by participation in the study

Other

  • No PrCa diagnosis
  • PrCa diagnosis that is not deemed suitable for active surveillance at multi-disciplinary meeting

Who the study is looking for

  • Men ≥18 years old under the care of an Active Surveillance clinic.
  • Known diagnosis of PrCa, deemed suitable for Active surveillance at multi-disciplinary meeting (MDT).
  • Men at genetically higher PrCa risk who are either:
    • (1) Men of any ancestry with a positive family history of PrCa defined as:
  • Having a first degree relative (or second degree if through female line) with histologically or death certificate proven PrCa diagnosed at \<70 years
  • Having two relatives on the same side of the family with histologically or death certificate proven PrCa where at least one is diagnosed at \<70 years
  • Having three relatives on the same side of the family with histologically or death certificate proven PrCa diagnosed at any age
    • Or (2) Men of Black African or Black African-Caribbean ancestry defined as:
  • Both parents and all 4 grandparents from that origin Or (3) Men of any ancestry with a pathogenic mutation in a gene thought to cause a higher risk of prostate cancer: (including BRCA1, BRCA2, ATM, PALB2, MLH1, MSH2, MSH6, CHEK2 and other DNA repair gene mutations as listed in appendix A) Or (4) Men of any ancestry with a high genetic risk (common and/or rare variants) for PrCa resulting in a RR of ≥2 of PrCa
  • Men of any ancestry with no known high risk genetic factors who have been diagnosed with low grade PrCa and deemed suitable for Active Surveillance at multi-disciplinary meeting (control group) as defined in the 4 criteria above.
  • Who performance status 0-2
  • Absence of any psychological, familial, sociological, or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
North Bristol NHS Trust
Coordinator of this site? Confirm its status
BristolUnited KingdomNot yet recruiting
The Royal Marsden Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting
The Royal Marsden Hospital
Coordinator of this site? Confirm its status
SuttonUnited KingdomRecruiting
Institute of Cancer Research and Royal Marsden Hospital
Coordinator of this site? Confirm its status
SuttonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.