Observing biomarkers in men with prostate cancer on active surveillance

Active Surveillance Study for Prostate Cancer Management for Men at Higher Genetic Risk Compared With Men at No Known Higher Genetic Risk.

This study is testing how certain biological markers relate to the progression of prostate cancer in men on active surveillance, focusing on those with different genetic risks.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Institute of Cancer Research, United Kingdom (Academic / other)
• Locations: 4 sites (Sutton, Surrey and 3 other locations)
• Trial ID: NCT05810467 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with a diagnosis of low-grade prostate cancer who are undergoing active surveillance and have either a known higher genetic risk or no increased genetic risk.

Not a fit: Patients with aggressive prostate cancer or those not eligible for active surveillance may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and management strategies for men with prostate cancer based on their genetic risk profiles.

How similar studies have performed: Other studies have shown promise in using biomarkers for monitoring prostate cancer, but this specific approach focusing on genetic risk is relatively novel.

Eligibility criteria

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 this trial is running

Sutton, Surrey and 3 other locations

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

Study contacts

• Principal investigator: Ros A Eeles, FRCP, FRFR — Institute of Cancer Research and Royal Marsden Hospital
• Study coordinator: Eva McGrowder, PhD

Conditions Prostate Cancer