Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Collaborating Sponsors:
King's College London
Uppsala University
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
Brief Summary
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 ...
Detailed Description
STUDY HYPOTHESIS The aim of this trial is to test the safety of an Active Surveillance protocol comparing current practice to standardized triggers for initiation of curative treatment, based on Magne...
Eligibility Criteria
Inclusion
- Recently (within 12 months) diagnosed adenocarcinoma of the prostate
- Tumour stage ≤ T2a, NX, M0 (former MX)
- PSA \<15ng/ml, PSA density ≤ 0.2 ng/ml/cm3
- Gleason pattern 3+3=6 (any number of cores, any cancer involvement) or Gleason pattern 3+4=7 (\<3 cores (or ≤30 % of cores if more than ten cores), \<10 mm cancer in one core)
- Life expectancy \>10 years with no upper age limit\*
- Candidate for curative treatment if progression occurs
- Signed written informed consent.
- There is no upper age limit; however the estimated remaining lifetime for the patient should be more than ten years. The potential life expectancy of the participants should be estimated based on age, co-morbidity and risk factors for death, such as frailty and smoking.
Exclusion
- Not eligible for AS according to above criteria
- Not competent in spoken or written English
Key Trial Info
Start Date :
September 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2033
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT04029714
Start Date
September 19 2019
End Date
December 1 2033
Last Update
February 23 2024
Active Locations (5)
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1
Bedford Hospital
Bedford, United Kingdom
2
Epsom & St. Helier
London, United Kingdom
3
Guy's Hospital
London, United Kingdom
4
Queen Elizabeth Hospital
London, United Kingdom