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Published in: BMC Cancer 1/2017

Open Access 01-12-2017 | Study protocol

Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol

Authors: Marie Lange, Heidi Laviec, Hélène Castel, Natacha Heutte, Alexandra Leconte, Isabelle Léger, Bénédicte Giffard, Aurélie Capel, Martine Dubois, Bénédicte Clarisse, Elodie Coquan, Frédéric Di Fiore, Sophie Gouérant, Philippe Bartélémy, Laure Pierard, Karim Fizazi, Florence Joly

Published in: BMC Cancer | Issue 1/2017

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Abstract

Background

New generation hormone-therapies (NGHT) targeting the androgen signalling pathway are nowadays proposed to elderly patients with metastatic castration-resistant prostate cancer (CRPCa). The impact of these treatments on cognitive function has never been evaluated whereas cognitive impairment may have an impact on the autonomy and the treatment adherence. The aim of this study is to prospectively assess the incidence of cognitive impairment in elderly men after treatment by NGHT for a metastatic CRPCa.

Methods/design

The Cog-Pro study is a multicentre longitudinal study including CRPCa patients ≥70 years old treated with NGHT (n = 134), control metastatic prostate cancer patients without castration resistance treated with first generation androgen deprivation therapy (n = 55), and healthy participants (n = 33), matched on age and education. Cognitive, geriatric and quality of life assessment and biological tests will be performed at baseline, 3, 6 and 12 months after start of the treatment (inclusion time). The primary endpoint is the proportion of elderly patients receiving a NGHT who will experience a decline in cognitive performances within 3 months after study enrollment. Secondary endpoints concern: autonomy, quality of life, anxiety, depression, cognitive reserve, adherence to hormone-therapy, comparison of the cognitive impact of 2 different NGHT (abiraterone acetate and enzalutamide), impact of co-morbidities and biological assessments.

Discussion

Evaluating, understanding and analyzing the incidence, severity of cognitive impairments and their impact on quality of life, autonomy and adherence in this group of patients with advanced disease is a challenge. This study should help to improve cancer care of elderly patients and secure the use of oral treatments as the risk of non-observance does exist. Our results will provide up-to date information for patients and caregivers on impact of these treatments on cognitive function in order to help the physicians in the choice of the treatment.

Trial registration

NCT02907372, registered: July 26, 2016.
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Metadata
Title
Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol
Authors
Marie Lange
Heidi Laviec
Hélène Castel
Natacha Heutte
Alexandra Leconte
Isabelle Léger
Bénédicte Giffard
Aurélie Capel
Martine Dubois
Bénédicte Clarisse
Elodie Coquan
Frédéric Di Fiore
Sophie Gouérant
Philippe Bartélémy
Laure Pierard
Karim Fizazi
Florence Joly
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2017
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-017-3534-8

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