PROState pathway embedded comparative trial: the IP3-PROSPECT study
PROState pathway embedded comparative trial: the IP3-PROSPECT study
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.
Clinical trials, Cohort multiple randomised controlled trial, Prostate cancer, cmRCT
Bass, E J
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Klimowska-Nassar, N
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Sasikaran, T
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Day, E
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Fiorentino, F
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Sydes, M R
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Winkler, M
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Arumainayagam, N
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Khoubehi, B
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Pope, A
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Sokhi, H
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Dudderidge, T
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Ahmed, H U
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1 August 2021
Bass, E J
c314db35-31b5-4180-b8e0-a72b94e1a8f3
Klimowska-Nassar, N
3f43d195-d42a-4e7c-8c88-8c30879eb25f
Sasikaran, T
2b0e6f6b-915b-468f-833f-2e0159ac09b7
Day, E
b15ac4a7-e8c5-40f6-b6ad-51fcf13ec056
Fiorentino, F
e7bed6cb-dccf-437d-b58d-844bfc4e280a
Sydes, M R
74f846e5-4690-452a-b0d8-5ca43c02dfa4
Winkler, M
e6716c20-4946-4466-bf05-76551c97e817
Arumainayagam, N
18edffe6-b0fd-48e8-bc8b-a2c3f24171da
Khoubehi, B
8a8f2f2d-f227-41b8-9f9b-c75add4e62e9
Pope, A
085de5de-251b-445f-849e-bae46a885004
Sokhi, H
bbfcc804-91bb-44f8-a2c2-e5a2257be148
Dudderidge, T
dae51cb9-9192-4352-9d7e-c7b2fcc4031a
Ahmed, H U
7b734f18-b6ca-4b08-9c15-8570a2b4e4d1
Bass, E J, Klimowska-Nassar, N, Sasikaran, T, Day, E, Fiorentino, F, Sydes, M R, Winkler, M, Arumainayagam, N, Khoubehi, B, Pope, A, Sokhi, H, Dudderidge, T and Ahmed, H U
(2021)
PROState pathway embedded comparative trial: the IP3-PROSPECT study.
Contemporary Clinical Trials, 107, [106485].
(doi:10.1016/j.cct.2021.106485).
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.
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More information
Accepted/In Press date: 10 June 2021
e-pub ahead of print date: 15 June 2021
Published date: 1 August 2021
Keywords:
Clinical trials, Cohort multiple randomised controlled trial, Prostate cancer, cmRCT
Identifiers
Local EPrints ID: 453410
URI: http://eprints.soton.ac.uk/id/eprint/453410
ISSN: 1551-7144
PURE UUID: 5ed2ad13-9242-4b9b-9ced-3e9950d223d1
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Date deposited: 13 Jan 2022 18:24
Last modified: 16 Mar 2024 14:31
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Contributors
Author:
E J Bass
Author:
N Klimowska-Nassar
Author:
T Sasikaran
Author:
E Day
Author:
F Fiorentino
Author:
M R Sydes
Author:
M Winkler
Author:
N Arumainayagam
Author:
B Khoubehi
Author:
A Pope
Author:
H Sokhi
Author:
T Dudderidge
Author:
H U Ahmed
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