The Active Surveillance Study
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorInstitute of Cancer Research, United Kingdom
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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
Disqualifiers
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
Trial population
* Control group (i.e., no known high PrCa risk): 100 men * Men at genetically higher PrCa risk: 100 men
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Active Surveillance
Other interventionActive 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control Arm1 intervention
Group B: High-risk Arm1 intervention
Trial outcomes
Primary outcomes
1
To determine the incidence of disease progression of PrCa in the cohorts studied.
Descriptive statistics will be used to determine and compare the characteristics of cancers in each cohort at recruitment. Disease progression will be classified as a Y/N indicator in order to look at the proportion of those progressing in each cohort, using logistic regression to adjust for covariates of interest, such as age at diagnosis, tumour-node-metastasis stage, and Gleason score. Rate ratios for the cumulative incidence of disease progression for any disease, compared between the two cohorts, will be calculated using Poisson regression offset by person-years of follow-up, adjusting for covariates of interest.
Time frame
The full analysis being completed within one year of date of completion of 5 year follow-up of the last participant.2
To determine the incidence of aggressiveness of PrCa in the cohorts studied.
Participants will be defined as experiencing disease progression if they have an upstaging or progression of their disease on MRI or biopsy. i.e., change in MRI or change in Gleason. Rate ratios for the cumulative incidence of aggressive disease (defined as progression on MRI or biopsy that results in the need for active treatment within one year of starting AS), compared between the two cohorts, will be calculated using Poisson regression offset by person-years of follow-up, adjusting for covariates of interest.
Time frame
The full analysis being completed within one year of date of completion of 5 year follow-up of the last participant.Secondary outcomes
1
To investigate the role of biomarker profiles in men undergoing active surveillance who are also at genetically higher risk for PrCa.
We will focus on DW-MRI at diagnosis, again using descriptive statistics and time-to-event analyses to break down the incidence of disease progression in each cohort and determine the association and interaction between higher genetic risk and DW-MRI.
Time frame
5 years2
To investigate the role of biomarker profiles in men undergoing active surveillance who are also at genetically higher risk for PrCa.
We will focus on metabolites using descriptive statistics and time-to-event analyses to break down the incidence of disease progression in each cohort and determine the association and interaction between higher genetic risk and metabolite levels.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Cancer Research, United Kingdom
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
North Bristol NHS Trust
Collaborator
Source ClinicalTrials.gov