The Active Surveillance Study

Trial Title: The Active Surveillance Study

NCT ID: NCT05810467

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Active Surveillance
Description: 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.
Arm group label: Control Arm
Arm group label: High-risk Arm

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.

Detailed description: This prospective study will 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. The study will review the serial PSA and imaging data for men in AS comparing and contrasting the men of known higher genetic risk for PrCa with those without. Additionally, the study aims to collect samples to investigate the profile of plasma, serum, urine, stool and saliva biomarkers in men at a higher genetic risk of PrCa, who have been diagnosed with low risk PrCa and are undergoing Active Surveillance. It will also review the association of specific genetic profiles and biomarkers (biological samples - plasma, serum, urine, stool and saliva). These markers will be compared and contrasted with samples from men with no known increased genetic risk for PrCa. The study aims to recruit a total of 200 men with low grade PrCa, aged ≥18 into two cohorts (i.e. men on AS who are known to be at higher genetic risk and those on AS with no known increased genetic risk of PrCa. Patients will be identified through the urology clinics at the Royal Marsden Hospital. These will be men who are already registered at the Royal Marsden Hospital and undergoing active surveillance (as determined by the MDT).

Criteria for eligibility:

Study pop:
- Control group (i.e., no known high PrCa risk): 100 men - Men at genetically higher PrCa risk: 100 men

Sampling method: Non-Probability Sample
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

Gender: Male

Gender based: Yes

Gender description: Assigned male at birth.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Institute of Cancer Research and Royal Marsden Hospital

Address:
City: Sutton
Zip: SM2 5PT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Rosalind A Eeles, FRCP FRFR

Phone: 02086613642
Email: rosalind.eeles@icr.ac.uk

Contact backup:
Last name: Rosalind A Eeles, FRCP FRCR

Start date: August 22, 2023

Completion date: December 2027

Lead sponsor:
Agency: Institute of Cancer Research, United Kingdom
Agency class: Other

Collaborator:
Agency: Royal Marsden NHS Foundation Trust
Agency class: Other

Source: Institute of Cancer Research, United Kingdom

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05810467