PROState Pathway Embedded Comparative Trial

Sponsor
Imperial College London
Study ID
NCT04400656
Status
Completed

Conditions

  • Metastatic Prostate Cancer
  • Metastatic Prostate Carcinoma in the Soft Tissue
  • Non-metastatic Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer
  • Prostate Cancer Metastatic

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 8, 2020
Status verified
Jun 2025
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022

Study Design

Enrollment
139 participants (actual)

Primary Outcome Measure

Number of Men Who Consented to Inclusion in PROSPECT Study Out of Total Number of Patients Approached [ Time Frame: from baseline to 23 months ]

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