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PROState Pathway Embedded Comparative Trial

NCT04400656 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2025-06-18

Study results available
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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 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.

Conditions

Sponsors & Collaborators

  • Imperial Clinical Trials Unit (ICTU)

    collaborator UNKNOWN

  • Wellcome Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Hashim Ahmed · Imperial College London

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04400656 on ClinicalTrials.gov