The Active Surveillance Study

Recruiting now

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05810467

Run by

Institute of Cancer Research, United Kingdom

People needed

200

Starts

2023-08-22

Expected to finish

2027-12-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• No PrCa diagnosis
• PrCa diagnosis that is not deemed suitable for active surveillance at multi-disciplinary meeting
• Any significant psychological conditions that may be worsened or exacerbated by participation in the study

Where it is running

• Institute of Cancer Research and Royal Marsden Hospital — Sutton, Surrey, United Kingdom (enrolling)
• The Royal Marsden Hospital — London, United Kingdom (enrolling)
• The Royal Marsden Hospital — Sutton, United Kingdom (enrolling)
• North Bristol NHS Trust — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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