The Active Surveillance Study

Launched by INSTITUTE OF CANCER RESEARCH, UNITED KINGDOM · Apr 11, 2023

Keywords

ClinConnect Summary

The Active Surveillance Study is a research project aimed at understanding how certain genetic factors might influence the presentation and progression of prostate cancer (PrCa) in men who are being monitored without immediate treatment. This study is specifically looking at men who are at higher genetic risk for prostate cancer and will help identify how these risks can affect the disease over time. The goal is to gather more information that could improve care for patients with prostate cancer.

To participate in this study, men must be at least 18 years old and under the care of the Active Surveillance clinic at the Royal Marsden Hospital. Eligible participants include those with a diagnosis of prostate cancer who are considered suitable for active surveillance, especially those with a family history of prostate cancer or specific genetic mutations that increase their risk. Participants will be monitored closely and can expect regular assessments to track their health and cancer progression. It's important to note that those with significant psychological issues or other health concerns that could interfere with the study will not be eligible. This study is currently recruiting participants, and it aims to contribute valuable insights into prostate cancer management.

Gender

MALE

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