Trial results for a study exploring a new trial design in Prostate Cancer were posted on ClinicalTrials.gov on 2025-06-18, involving 139 participants. The study focused on the acceptability and feasibility of the cohort-multiple RCT (cmRCT) design.
Background
Prostate cancer is a common condition, often managed as a chronic illness due to its long natural history. Innovative approaches to trial design, interventions, and management could significantly benefit patients and healthcare systems. This study explored the cohort-multiple RCT (cmRCT) or Trials WithIn Cohorts (TWICS) design, which has been used in other disease areas to streamline research processes and improve patient outcomes.
Trial design
This completed study, titled "PROState Pathway Embedded Comparative Trial" (PROSPECT), enrolled 139 participants. It investigated conditions including Prostate Cancer, Non-metastatic Prostate Cancer, Metastatic Prostate Cancer, Prostate Adenocarcinoma, and Metastatic Prostate Carcinoma in the Soft Tissue. The trial aimed to explore the feasibility and acceptability of the cohort-multiple RCT (cmRCT) or Trials WithIn Cohorts (TWICS) trial design, rather than evaluating a specific therapeutic intervention.
Key results
The trial reported several key measurements related to the acceptability and completeness of data collection:
- For the acceptability endpoint, the consent rate for inclusion in the PROSPECT study was measured at 36.2 percentage of participants.
- The approached rate, representing the number of participants approached out of those referred, was 83.1 percentage of participants.
- Regarding the completeness of Quality of Life (EQ5D-5L) questionnaire data, the number of participants who completed the questionnaire varied across different reporting periods, including 109, 96, 95, and 24 participants for "Proportion Responded" and 109, 96, 93, and 24 participants for "Proportion Completed".
- For the completeness of Quality of Life (EPIC-26) questionnaire data, 110 participants responded, and 107 participants completed the questionnaire.
What this means
The results provide insights into the operational feasibility and participant engagement for a cohort-multiple RCT design in the context of prostate cancer. The reported consent rate of 36.2% and approached rate of 83.1% offer specific metrics on participant recruitment and willingness to engage with the study design. The data on questionnaire completeness for EQ5D-5L and EPIC-26 indicates varying levels of data capture, which is valuable for understanding the practical challenges and successes of implementing such a trial design in a real-world setting. These findings contribute to the methodology of clinical research rather than direct clinical outcomes for prostate cancer treatment.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04400656, titled "PROState Pathway Embedded Comparative Trial", were posted on 2025-06-18 on clinicaltrials.gov.