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

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.

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.

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.

NCT02907372 , registered: July 26, 2016.

BMC cancer. 2017 Aug 16*** epublish ***

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

INSERM, U1086 ANTICIPE, Normandie University, UNICAEN, 14076, Caen, France., Medical Oncology Department, Centre François Baclesse, 14076, Caen, France., Cancer and Cognition Platform, Ligue Nationale Contre le Cancer, 14076, Caen, France., Clinical Research Department, Centre François Baclesse, 14076, Caen, France., Medical Oncology Department, Centre Henri-Becquerel, 76000, Rouen, France., Medical Oncology and Hematology Department, Hôpitaux Universitaires de Strasbourg, 67000, Strasbourg, France., Medical Oncology Department, Gustave Roussy, 94800, Villejuif, France., INSERM, U1086 ANTICIPE, Normandie University, UNICAEN, 14076, Caen, France. .