IP-3 PROSPECT
Research type
Research Study
Full title
IP-3: PROState Pathway Embedded Comparative Trial (PROSPECT)
IRAS ID
272985
Contact name
Hashim Uddin Ahmed
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Our study will explore a trial design called the cohort-multiple RCT (cmRCT) or the so-called Trials WithIn Cohorts (TWICS) design. This design has been used in a number of disease areas, both benign and cancer. We have chosen prostate conditions since they are extremely common and if malignancy occurs the majority of men with the disease are regarded as living with a chronic condition due to its long natural history and in which innovative approaches, interventions, treatments or changes in management might have a significant patient benefit and impact on the NHS. It therefore fits the cmRCT design very well.
The cmRCT design is currently being used in elderly patients, risk of falls, depression, hip fracture, Yorkshire Health Study, scleroderma, breast cancer, colorectal cancer, bladder cancer and kidney cancer, to name a few. In total, a recent systematic review showed that there were 18 ongoing cmRCT studies with 6 in the UK.
We want to test the acceptability and feasibility of the cmRCT in the prostate pathway. As this is the first time that we are trying out this method we need to first evaluate it. In the first part of the study, we want to evaluate the following. What is the accrual rate? What do patients and their healthcare professionals think of the cmRCT design? Is the data we collect robust? What are the resource requirements of such a study?
Summary of Results
This study represents the first successful recruitment to a cohort multiple Randomized Controlled Trial (cmRCT) in prostate cancer, demonstrating high interest among patients. Recruitment began in September 2020 across four sites, with 139 patients enrolled and a recruitment rate of 35.3%. Data collection was highly successful, with over 90% completeness in all categories, though the return of Patient-Reported Outcome Measures (PROMs) decreased over time, especially among non-cancer patients. Ten patients participated in interviews at the start of the trial, none of whom withdrew, with most motivated by altruism and interest in new treatments. There were no concerns about being in a control group or long-term follow-up. Reasons for non-participation were more varied. Additionally, ten healthcare professionals, including surgeons, trainees, nurses, and research managers, were interviewed, revealing that while the pragmatic approach of the study was beneficial, challenges remain. Moving forward, the platform aims to serve as a vehicle for testing novel interventions in prostate cancer.
REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/0459
Date of REC Opinion
21 May 2020
REC opinion
Further Information Favourable Opinion