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PROState Pathway Embedded Comparative Trial: The IP3-PROSPECT study.

E J Bass1, N Klimowska-Nassar2, T Sasikaran2

  • 1Imperial Prostate, Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK.

Contemporary Clinical Trials
|June 17, 2021
PubMed
Summary
This summary is machine-generated.

The IP3-PROSPECT study pilots a novel cohort multiple randomized controlled trial (cmRCT) design to improve prostate cancer research recruitment. This innovative approach aims to generate robust comparative data for multiple interventions in localized prostate cancer.

Keywords:
Clinical trialsCohort multiple randomised controlled trialProstate cancercmRCT

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Area of Science:

  • Oncology
  • Clinical Trials
  • Health Services Research

Background:

  • Traditional randomized controlled trials (RCTs) face challenges in participant accrual, especially for localized prostate cancer.
  • The cohort multiple randomized controlled trial (cmRCT) offers a potential solution for generating robust comparative data.

Purpose of the Study:

  • To evaluate the acceptability and feasibility of the IP3-PROSPECT cmRCT design in prostate cancer.
  • To assess the potential of cmRCTs for building a modern evidence base in prostate cancer research.

Main Methods:

  • The IP3-PROSPECT study utilizes a two-point consent process for eligible men referred for prostate cancer investigations.
  • Acceptability and feasibility are measured using quantitative (consent rates, data completeness, questionnaire return) and qualitative (patient and healthcare professional interviews) methods.

Main Results:

  • The primary outcome is the consent rate for inclusion in the IP3-PROSPECT cohort.
  • Secondary outcomes include data collection completeness and patient questionnaire return rates.
  • Qualitative data will explore the implementation, practicality, and efficiency of the cmRCT design.

Conclusions:

  • The IP3-PROSPECT study will pilot and assess the cmRCT design in the context of prostate cancer.
  • The cmRCT represents an innovative approach with the potential to enhance comparative effectiveness research in prostate cancer.