NCT04029714Active, 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
A Multicentre Randomised Active Surveillance (AS) Trial of Current Practice Versus Standardised Triggers for Curative Treatment of Prostate Cancer
Source: ClinicalTrials.gov · Last updated 23 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 195 (actual)
- First submitted
- 16 Jul 2019
- Start date
- 19 Sept 2019
- Primary completion date
- Dec 2033
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT04029714
What you commit to
- Study type: Interventional
- Participants enrolled: 195
- From 19 Sept 2019 to the primary completion date, Dec 2033
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not eligible for AS according to above criteria
- Not competent in spoken or written English
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bedford Hospital Coordinator of this site? Confirm its status | Bedford | United Kingdom | Unknown status |
| Epsom & St. Helier Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Guy's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Mardsen Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.