Prostate Cancer Active Surveillance Trigger Trial (PCASTT - UK)
Research type
Research Study
Full title
A multicentre randomised Active Surveillance trial of current practice versus standardised triggers for curative treatment
IRAS ID
228445
Contact name
Mieke Van Hemelrijck
Contact email
Sponsor organisation
King’s College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 11 months, 31 days
Research summary
Widespread prostate cancer specific antigen (PSA) testing of asymptomatic men has dramatically increased the recorded incidence of prostate cancer in many western countries. It is now widely accepted that a large proportion of these men are overdiagnosed, because they have non-lethal disease, and overtreated with substantial side effects. To reduce overtreatment and adverse effects, active surveillance has emerged as a viable option that should be offered to patients with low-risk prostate cancer.
By monitoring disease progression, or lack thereof, and keeping the option to recommend radical local treatment open for a certain period of time, active surveillance might convey substantial benefits compared with routine initial prostatectomy or radiotherapy. There is, however, a lack of randomized evidence for when disease progression should trigger radical treatment with a curative intent in men who are on active surveillance.
To fill this problematic knowledge gap, the Scandinavian Prostatic Cancer Group is promoting a large multicentre randomized trial, called SPCG-17. The aim of this trial is to test the safety of an active surveillance protocol comparing current practice with standardized triggers for initiation of curative treatment. The primary endpoint is progression-free survival, based on the cumulative incidence of indicators of prostate cancer progression. This trial is open and running in Sweden and Finland, and has approval to begin in Norway. We propose to run a similar RCT in the UK which will add to the findings from SPCG-17.
Currently, across the UK, decisions to re-biopsy and initiate curative treatment are not guided by any set criteria and tend to be at the clinician’s discretion. The PCASTT-UK trial aims to test a set of standardised rules around when to undertake a repeat biopsy and when to initiate curative treatment for men on active surveillance. In all other respects standard care will remain the same.REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0314
Date of REC Opinion
10 Jan 2019
REC opinion
Further Information Favourable Opinion