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Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate
Marie Lange1,2,3, Heidi Laviec4, Hélène Castel3,5
1INSERM, U1086 ANTICIPE, Normandie University, UNICAEN, 14076, Caen, France.
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.
Insights
This study investigates cognitive decline in elderly men with metastatic castration-resistant prostate cancer (CRPCa) treated with new generation hormone therapies (NGHT). Results will inform patient care and treatment choices regarding NGHT side effects on cognition.
Area of Science:
- Oncology
- Geriatrics
- Neuroscience
Background:
- New generation hormone therapies (NGHT) targeting the androgen signaling pathway are used for metastatic castration-resistant prostate cancer (CRPCa) in elderly patients.
- The impact of NGHT on cognitive function in this population remains unevaluated, despite potential effects on patient autonomy and treatment adherence.
- Cognitive impairment can significantly affect the quality of life and self-management of elderly cancer patients.
Purpose of the Study:
- To prospectively assess the incidence of cognitive impairment in elderly men undergoing NGHT for metastatic CRPCa.
- To evaluate the impact of NGHT on cognitive performance, autonomy, quality of life, and treatment adherence.
- To compare the cognitive effects of different NGHT (abiraterone acetate and enzalutamide) and identify influencing factors like comorbidities.
Main Methods:
- The Cog-Pro study is a multicenter, longitudinal study involving CRPCa patients (≥70 years) on NGHT (n=134), control prostate cancer patients on first-generation androgen deprivation therapy (n=55), and healthy participants (n=33).
- Cognitive, geriatric, quality of life, and biological assessments were conducted at baseline, 3, 6, and 12 months post-treatment initiation.
- The primary endpoint was the proportion of patients experiencing cognitive decline within 3 months of NGHT initiation.
Main Results:
- The study aims to determine the primary endpoint: the proportion of elderly patients receiving NGHT who experience cognitive decline within 3 months.
- Secondary endpoints include changes in autonomy, quality of life, anxiety, depression, cognitive reserve, and treatment adherence.
- Analysis will also compare cognitive impacts between abiraterone acetate and enzalutamide, and assess the influence of comorbidities and biological factors.
Conclusions:
- Assessing cognitive impairment incidence, severity, and impact on quality of life, autonomy, and adherence in advanced prostate cancer patients is crucial.
- Findings will enhance cancer care for elderly patients and support the safe use of oral hormone therapies by highlighting adherence risks.
- Results will provide valuable information for patients, caregivers, and physicians to guide treatment decisions regarding NGHT and cognitive function.
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