Prostate Pathway Embedded Comparative Trial: Outcomes from the Pilot Phase of the Imperial Prostate 3-PROState Pathway Embedded Comparative Trial.

[BACKGROUND AND OBJECTIVE] Rapid innovations in prostate cancer diagnosis and treatment have led to the adoption of innovative trial designs. The Imperial Prostate 3-PROState Pathway Embedded Comparative Trial (IP3-PROSPECT) aims to explore the feasibility and acceptability of a cohort multiple randomised controlled trial (cmRCT) design within the prostate cancer pathway.

[METHODS] Eligible participants were approached at the point of referral for a clinical suspicion of prostate cancer and were invited to join the cohort, agreeing in principle to future randomisations, without knowledge of the details of those interventions. Patients completed patient-reported outcome measure (PROM) questionnaires at baseline and follow-up visits, providing valuable insights into their experiences following prostate cancer diagnosis.

[KEY FINDINGS AND LIMITATIONS] IP3-PROSPECT recruited 139 participants from 384 individuals approached across four sites, meeting the primary endpoint with an approach rate of 35.3%. Recruitment outcomes demonstrated the feasibility of recruiting patients to the cmRCT cohort within the prostate cancer pathway, with high completion rates for PROM questionnaires observed throughout the study visits. Participants and health care professionals expressed favourable views towards the design, acknowledging its potential advantages over traditional trial designs. Sufficient interventions that span the prostate pathway so that the potential large number of participants could be involved in answering research questions as well as the need to optimise recruitment strategies were identified.

[CONCLUSIONS AND CLINICAL IMPLICATIONS] IP3-PROSPECT provides valuable insights into the feasibility and acceptability of implementing a cmRCT design within the prostate cancer pathway. Future research will evaluate the effectiveness of the cmRCT design in generating comparative effectiveness data for prostate cancer interventions.