Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT05810467
Eligibility Criteria:
Inclusion Criteria:
* Men ≥18 years old under the care of the Active Surveillance clinic in the Royal Marsden Hospital (RMH).
* 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 European 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 Caribbean ancestry defined as:
\- Both parents and all 4 grandparents from that origin Or (3) Men 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 with a high genetic risk (common and/or rare variants) for PrCa resulting in a RR of ≥2 of PrCa
* Men 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 (see Appendix B)
* Absence of any psychological, familial, sociological, or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05810467
Study Brief:
Protocol Section:
NCT05810467