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Prostate Cancer Active Surveillance Trigger Trial (PCASTT-UK): Comparing Current Practice for Men With Prostate Cancer on Active Surveillance (AS) to an AS Protocol With Standardised Triggers for Transitioning to Curative Treatment

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 500 to confirmed 195
    • Site details revised at 5 of 5 sites
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2030 to Dec 2033
    • Study sites: 0 to 5
    • Start date changed from estimate of Aug 2019 to Sep 19, 2019
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumour progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. Therefore, the Scandinavian Prostate Cancer Group (SPCG) are running a large multi-centre randomised control trial (RCT) to test the safety of a standardized active surveillance protocol with specific triggers for repeat biopsies and initiation of curative treatment, compared to the current practice for active surveillance. They are recruiting in multiple sites in Sweden, Denmark and Finland. The primary aim is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality. In the UK, there is also no set criteria for when to re-biopsy and/or initiate curative treatment for patients on AS and tends to be at the clinician's discretion. Thus, PCASTT-UK has been established to run as a parallel RCT and add to the findings from SPCG-17.
Trial Details
NCT Number NCT04029714
Lead Sponsor Guy's and St Thomas' NHS Foundation Trust
Collaborators: King's College London, Uppsala University
Conditions
(from sponsor)
Prostate Cancer
Related terms Prostatic Neoplasms
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov