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 disease areas, both benign and cancer. Prostate conditions have been chosen 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. Nonetheless, the lessons learned in this study will be of relevance to other disease spaces. The TWICS or 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. The acceptability and feasibility of the cmRCT in the prostate pathway will be tested. This is the first time this method will be tested and therefore piloted. In the first part of the study, the following will be evaluated. What is the accrual rate? What do patients and their healthcare professionals think of the cmRCT design? Is the data collected robust? What are the resource requirements of such a study?A number of novel interventions or changes in the pathway will then be tested and compared to standard care in the cohort that was recruited.
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Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached
Timeframe: from baseline to 23 months
Number of Participants Approached for the Study From the Number of Patients Referred to the Study Team by Other Participating Centres
Timeframe: from baseline to 23 months
Number of Participants Who Complete a Questionnaire on the Quality of Life (EQ5D-5L)
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants Who Complete a Questionnaire on Quality of Life (EPIC-26)
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants Who Complete a Questionnaire on Quality of Life (IPSS)
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.
Number of Participants Who Complete a Questionnaire on Quality of Life (IIEF-15)
Timeframe: Questionnaire was completed at baseline - 0 months, visit 1 - 6 months, visit 2 -12 months and visit 3 -18 months.