UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

PROState pathway embedded comparative trial: The IP3-PROSPECT study

Bass, EJ; Klimowska-Nassar, N; Sasikaran, T; Day, E; Fiorentino, F; Sydes, MR; Winkler, M; ... Ahmed, HU; + view all (2021) PROState pathway embedded comparative trial: The IP3-PROSPECT study. Contemporary Clinical Trials , 107 , Article 106485. 10.1016/j.cct.2021.106485. Green open access

[thumbnail of 1-s2.0-S1551714421002214-main.pdf]
Preview
Text
1-s2.0-S1551714421002214-main.pdf

Download (1MB) | Preview

Abstract

INTRODUCTION: The traditional double blind RCT is the 'gold standard' trial design. For a variety of reasons, these designs often fail to accrue enough participants to conclude. This is particularly challenging in localized prostate cancer. The cohort multiple randomised controlled trial (cmRCT) trial design may represent an alternative approach to delivering robust comparative data in prostate cancer. PATIENTS AND METHODS: IP3-PROSPECT is a cmRCT designed to test multiple prostate cancer interventions from eligible men in one cohort. Key to the design is two points of consent. First, at point of consent one, men referred for prostate cancer investigations are invited to join the cohort. They may then be randomly invited at a later date to consider an intervention at point of consent two. In the pilot phase we will test the acceptability and feasibility of developing the cohort. RESULTS: Acceptability and feasibility of the study will be measured by a combination of quantitative and qualitative methods. The primary outcome measure is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcome measures include the completeness of data collection at sites and return rates of patient questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT. CONCLUSION: The IP3-PROSPECT study will evaluate the cmRCT design in prostate cancer. Initially we will pilot the design, assessing for acceptability and feasibility. The cmRCT is an innovative design that offers potential for building a modern comparative evidence base for prostate cancer.

Type: Article
Title: PROState pathway embedded comparative trial: The IP3-PROSPECT study
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.cct.2021.106485
Publisher version: http://dx.doi.org/10.1016/j.cct.2021.106485
Language: English
Additional information: © 2021 Published by Elsevier Ltd. This is an open access article under the CC BY 4.0 license Attribution 4.0 International (https://creativecommons.org/licenses/by/4.0/)
Keywords: Clinical trials, Cohort multiple randomised controlled trial, Prostate cancer, cmRCT
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10130760
Downloads since deposit
21Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item