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

Double-Blind Method Feasibility Studies Health Personnel Humans Male Prospective Studies Prostate Surveys and Questionnaires
Clinical trials Cohort multiple randomised controlled trial Prostate cancer cmRCT

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
08 2021
Historique:
received: 23 11 2020
revised: 07 06 2021
accepted: 10 06 2021
pubmed: 18 6 2021
medline: 25 9 2021
entrez: 17 6 2021
Statut: ppublish

Résumé

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. 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. 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. 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.

Identifiants

DOI: 10.1016/j.cct.2021.106485 PMID: 34139356 PMC: PMC8451266
pubmed: 34139356
pii: S1551-7144(21)00221-4
doi: 10.1016/j.cct.2021.106485
pmc: PMC8451266
pii:
doi:

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

106485

Subventions

Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_00004/08
Pays : United Kingdom
Organisme : Medical Research Council
ID : MC_UU_12023/24
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 204998/Z/16/Z
Pays : United Kingdom

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

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Auteurs

E J Bass (EJ)

Imperial 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. Electronic address: ebass@ic.ac.uk.

N Klimowska-Nassar (N)

Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.

T Sasikaran (T)

Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.

E Day (E)

Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.

F Fiorentino (F)

Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Imperial Clinical Trials Unit, School of Public Health, Faculty of Medicine, Imperial College London, London, UK.

M R Sydes (MR)

MRC Clinical Trials Unit at UCL, University College London, London, UK.

M Winkler (M)

Imperial 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.

N Arumainayagam (N)

Department of Urology, Ashford and St. Peter's Hospitals NHS Foundation Trust, St. Peter's Hospital, Chertsey, UK.

B Khoubehi (B)

Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK; Department of Urology, Chelsea and Westminster Hospitals NHS Foundation Trust, London, UK.

A Pope (A)

Imperial Urology, Division of Cancer, Cardiovascular Medicine and Surgery, Imperial College Healthcare NHS Trust, London, UK; Department of Urology, The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK.

H Sokhi (H)

Department of Radiology, The Hillingdon Hospitals NHS Foundation Trust, Uxbridge, UK.

T Dudderidge (T)

Department of Urology, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

H U Ahmed (HU)

Imperial 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.

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Classifications MeSH

questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › PROState Pathway Embedded Comparative Trial:...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études de faisabilité › PROState Pathway Embedded Comparative Trial:...
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questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › PROState Pathway Embedded Comparative Trial:...
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