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Metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research (IP5-MATTER): protocol for a prospective, multicentre discrete choice experiment study

Metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research (IP5-MATTER): protocol for a prospective, multicentre discrete choice experiment study
Metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research (IP5-MATTER): protocol for a prospective, multicentre discrete choice experiment study

INTRODUCTION: Systemic therapy with androgen deprivation therapy (ADT) and intensification with agents such as docetaxel, abiraterone acetate and enzalutamide has resulted in improved overall survival in men with de novo synchronous metastatic hormone-sensitive prostate cancer (mHSPC). Novel local cytoreductive treatments and metastasis-directed therapy are now being evaluated. Such interventions may provide added survival benefit or delay the requirement for further systemic agents and associated toxicity but can confer additional harm. Understanding men's preferences for treatment options in this disease state is crucial for patients, clinicians, carers and future healthcare service providers.

METHODS: Using a prospective, multicentre discrete choice experiment (DCE), we aim to determine the attributes associated with treatment that are most important to men with mHSPC. Furthermore, we plan to determine men's preferences for, and trade-offs between, the attributes (survival and side effects) of different treatment options including systemic therapy, local cytoreductive approaches (external beam radiotherapy, cytoreductive radical prostatectomy or minimally invasive ablative therapy) and metastases-directed therapies (metastasectomy or stereotactic ablative body radiotherapy). All men with newly diagnosed mHSPC within 4 months of commencing ADT and WHO performance status 0-2 are eligible. Men who have previously consented to a cytoreductive treatment or have developed castrate-resistant disease will be excluded. This study includes a qualitative analysis component, with patients (n=15) and healthcare professionals (n=5), to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation in a DCE. The main phase component planned recruitment is 300 patients over 1 year, commencing in January 2021, with planned study completion in March 2022.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Health Research Authority East of England, Cambridgeshire and Hertfordshire Research Ethics Committee (Reference: 20/EE/0194). Project information will be reported on the publicly available Imperial College London website and the Heath Economics Research Unit (HERU website including the HERU Blog). We will use the social media accounts of IP5-MATTER, Imperial Prostate London, HERU and the individual researchers to disseminate key findings following publication. Findings from the study will be presented at national/international conferences and peer-reviewed journals. Authorship policy will follow the recommendations of the International Committee of Medical Journal Editors.

TRIAL REGISTRATION NUMBER: NCT04590976.

Abiraterone Acetate, Androgen Antagonists, Attitude, Humans, Male, Multicenter Studies as Topic, Observational Studies as Topic, Prospective Studies, Prostatic Neoplasms/drug therapy
2044-6055
Connor, Martin John
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Genie, Mesfin G
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Gonzalez, Michael
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Sarwar, Naveed
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Thippu Jayaprakash, Kamalram
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Horan, Gail
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Hosking-Jervis, Feargus
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Klimowska-Nassar, Natalia
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Sukumar, Johanna
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Pokrovska, Tzveta
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Basak, Dolan
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Robinson, Angus
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Beresford, Mark
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Rai, Bhavan
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Mangar, Stephen
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Khoo, Vincent
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Dudderidge, Tim
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Falconer, Alison
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Winkler, Mathias
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Watson, Verity
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Ahmed, Hashim Uddin
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Connor, Martin John
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Genie, Mesfin G
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Gonzalez, Michael
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Sarwar, Naveed
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Thippu Jayaprakash, Kamalram
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Horan, Gail
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Hosking-Jervis, Feargus
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Klimowska-Nassar, Natalia
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Sukumar, Johanna
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Pokrovska, Tzveta
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Basak, Dolan
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Robinson, Angus
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Beresford, Mark
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Rai, Bhavan
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Mangar, Stephen
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Khoo, Vincent
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Dudderidge, Tim
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Falconer, Alison
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Winkler, Mathias
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Watson, Verity
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Ahmed, Hashim Uddin
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Connor, Martin John, Genie, Mesfin G, Gonzalez, Michael, Sarwar, Naveed, Thippu Jayaprakash, Kamalram, Horan, Gail, Hosking-Jervis, Feargus, Klimowska-Nassar, Natalia, Sukumar, Johanna, Pokrovska, Tzveta, Basak, Dolan, Robinson, Angus, Beresford, Mark, Rai, Bhavan, Mangar, Stephen, Khoo, Vincent, Dudderidge, Tim, Falconer, Alison, Winkler, Mathias, Watson, Verity and Ahmed, Hashim Uddin (2021) Metastatic prostate cancer men's attitudes towards treatment of the local tumour and metastasis evaluative research (IP5-MATTER): protocol for a prospective, multicentre discrete choice experiment study. BMJ Open, 11 (11), [e048996]. (doi:10.1136/bmjopen-2021-048996).

Record type: Article

Abstract

INTRODUCTION: Systemic therapy with androgen deprivation therapy (ADT) and intensification with agents such as docetaxel, abiraterone acetate and enzalutamide has resulted in improved overall survival in men with de novo synchronous metastatic hormone-sensitive prostate cancer (mHSPC). Novel local cytoreductive treatments and metastasis-directed therapy are now being evaluated. Such interventions may provide added survival benefit or delay the requirement for further systemic agents and associated toxicity but can confer additional harm. Understanding men's preferences for treatment options in this disease state is crucial for patients, clinicians, carers and future healthcare service providers.

METHODS: Using a prospective, multicentre discrete choice experiment (DCE), we aim to determine the attributes associated with treatment that are most important to men with mHSPC. Furthermore, we plan to determine men's preferences for, and trade-offs between, the attributes (survival and side effects) of different treatment options including systemic therapy, local cytoreductive approaches (external beam radiotherapy, cytoreductive radical prostatectomy or minimally invasive ablative therapy) and metastases-directed therapies (metastasectomy or stereotactic ablative body radiotherapy). All men with newly diagnosed mHSPC within 4 months of commencing ADT and WHO performance status 0-2 are eligible. Men who have previously consented to a cytoreductive treatment or have developed castrate-resistant disease will be excluded. This study includes a qualitative analysis component, with patients (n=15) and healthcare professionals (n=5), to identify and define the key attributes associated with treatment options that would warrant trade-off evaluation in a DCE. The main phase component planned recruitment is 300 patients over 1 year, commencing in January 2021, with planned study completion in March 2022.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Health Research Authority East of England, Cambridgeshire and Hertfordshire Research Ethics Committee (Reference: 20/EE/0194). Project information will be reported on the publicly available Imperial College London website and the Heath Economics Research Unit (HERU website including the HERU Blog). We will use the social media accounts of IP5-MATTER, Imperial Prostate London, HERU and the individual researchers to disseminate key findings following publication. Findings from the study will be presented at national/international conferences and peer-reviewed journals. Authorship policy will follow the recommendations of the International Committee of Medical Journal Editors.

TRIAL REGISTRATION NUMBER: NCT04590976.

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Accepted/In Press date: 21 October 2021
Published date: 18 November 2021
Additional Information: Funding MJC’s research is support by University College London Hospitals (UCLH) Charity and the Wellcome Trust. Mesfin Genie and Verity Watson are based at the Health Economics Research Unit (HERU), University of Aberdeen. HERU is funded by the Chief Scientists Office of the Scottish Government Health and Social Care Directorate. KTJ acknowledges research grant from the UK National Institute of Health Research Clinical Research Network Eastern and has received educational grants from Bayer UK, Janssen Oncology, Pfizer, Roche, and Takeda. HUA’s research is supported by core funding from the United Kingdom’s National Institute of Health Research (NIHR) Imperial Biomedical Research Centre.
Keywords: Abiraterone Acetate, Androgen Antagonists, Attitude, Humans, Male, Multicenter Studies as Topic, Observational Studies as Topic, Prospective Studies, Prostatic Neoplasms/drug therapy

Identifiers

Local EPrints ID: 454546
URI: http://eprints.soton.ac.uk/id/eprint/454546
ISSN: 2044-6055
PURE UUID: 7d6b602d-cbd0-4e4c-802e-adaaea4b59c4

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Date deposited: 16 Feb 2022 17:30
Last modified: 16 Mar 2024 15:46

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Contributors

Author: Martin John Connor
Author: Mesfin G Genie
Author: Michael Gonzalez
Author: Naveed Sarwar
Author: Kamalram Thippu Jayaprakash
Author: Gail Horan
Author: Feargus Hosking-Jervis
Author: Natalia Klimowska-Nassar
Author: Johanna Sukumar
Author: Tzveta Pokrovska
Author: Dolan Basak
Author: Angus Robinson
Author: Mark Beresford
Author: Bhavan Rai
Author: Stephen Mangar
Author: Vincent Khoo
Author: Tim Dudderidge
Author: Alison Falconer
Author: Mathias Winkler
Author: Verity Watson
Author: Hashim Uddin Ahmed

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