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

Inclusion Criteria12

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.

Exclusion Criteria3

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

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.