Status:
COMPLETED
PROState Pathway Embedded Comparative Trial
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Imperial Clinical Trials Unit (ICTU)
Wellcome Trust
Conditions:
Prostate Cancer
Non-metastatic Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
The proposal will explore a trial design called the cohort-multiple RCT (cmRCT) or as it has been recently coined, the Trials WithIn Cohorts (TWICS) design. This design has been used in a number of di...
Detailed Description
TRIAL AIMS The pilot phase of PROSPECT is interested in investigating the a) acceptability and feasibility of establishing the cohort of men, i.e. putting the questions of Point of Consent One to men...
Eligibility Criteria
Inclusion
- Men aged 18 years old and over who are referred for investigations for urinary symptoms or elevated serum prostate specific antigen (PSA) levels or other risk factors for possible prostate malignancy.
- An understanding of the English language sufficient to understand written and verbal information about the trial and consent process.
- Estimated life expectancy of 5 years or more.
- Signed informed consent.
Exclusion
- 1\. Men who are unable to give informed consent.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT04400656
Start Date
September 8 2020
End Date
August 31 2022
Last Update
June 18 2025
Active Locations (3)
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1
West Middlesex University Hospital
Isleworth, Middlesex, United Kingdom, TW7 6AF
2
Ashford & St Peter's Hospitals (ASPH) NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 0PZ
3
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF