Observing biomarkers in men with prostate cancer on active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Active Surveillance study is a prospective observational study aimed at understanding the relationship between biomarkers and prostate cancer (PrCa) progression among men undergoing active surveillance. It will stratify participants based on their genetic risk and analyze serial PSA and imaging data. The study will recruit 200 men diagnosed with low-grade PrCa, comparing those with known higher genetic risk to those without. Additionally, biological samples such as plasma, serum, urine, stool, and saliva will be collected to investigate the profiles of biomarkers associated with genetic risk. This research is conducted at the Royal Marsden Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria

* 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 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

Where it's running

• Institute of Cancer Research and Royal Marsden Hospital
  Sutton, Surrey, United Kingdom Recruiting
• The Royal Marsden Hospital
  London, United Kingdom Recruiting
• The Royal Marsden Hospital
  Sutton, United Kingdom Recruiting
• North Bristol NHS Trust
  Bristol, United Kingdom Not yet recruiting

Study contacts

• Principal investigator: Ros A Eeles, FRCP, FRFR — Institute of Cancer Research and Royal Marsden Hospital
• Study coordinator: Eva McGrowder, PhD
• Email: eva.mcgrowder@icr.ac.uk
• Phone: 02087224483

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.