Metastatic Castration-resistant Prostate Cancer (CRPCa) Clinical Trial
— COG-PROOfficial title:
Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer
| Verified date | January 2023 |
| Source | Centre Francois Baclesse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the impact of the novel oral hormonal agents (abiraterone acetate or enzalutamide) among elderly metastatic prostate cancer patients. This study will assess the influence of treatments on patients' cognitive functions on a longitudinal basis and evaluate the quality of life and the adherence of patients who had or develop cognitive disorders.
| Status | Completed |
| Enrollment | 163 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 70 Years and older |
| Eligibility | Inclusion Criteria: For the group of patients of interest : - Patient must have a metastatic castration-resistant prostate cancer (CRPCa) - Patient must be 70 years and more - Performance Status 0-2 - Patient must have not received chemotherapy except one line per Docetaxel for hormono-sensitive situation and which must be completed for a least 18 months before inclusion - Patient must have been already treated with first generation of androgen deprivation therapy - Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale = 3) - Patient must be candidate for a treatment by a new generation hormono-therapy (with abiraterone acetate or enzalutamide), in accordance to precautions of these treatments described in Summary Characteristics of Product and in combination with androgen deprivation therapy - Treatment with biphosphonates is authorized - No known brain metastasis - Patient must be at least on level 3 on school scale - Patient has signed informed consent For the control group of patients : - Patient with metastatic prostate cancer without resistance to castration - Patient must be 70 years and more - Performance Status 0-2 - Patient must have not received chemotherapy except one line per Docetaxel for hormono-sensitive situation and which must be completed for a least 18 months before inclusion - Patient must have already started the first generation of androgen deprivation therapy at least since 3 months - Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale = 3) - No known brain metastasis - Patient must be at least on level 3 on school scale - Patient has signed informed consent For the control group of healthy volunteers: - Man - No history of cancer, - 70-year old or more, - Health status consistent with the participation to the study - At least on level 3 on school scale - Signed informed consent Exclusion Criteria: For all participants (group of patients of interest, control group of patients and group of healthy volunteers): - No previous treatment with a new generation hormone therapy (abiraterone acetate or enzalutamide) - Neurological sequelae of (traumatic brain injury, stroke, multiple sclerosis, epilepsy, neuro-degenerative disease…) - Known evolutive psychiatric disorder - Drug use - Heavy drinking - Assessed to be unable or unwilling to comply with the requirements of the protocol For group of patients of interest, additional non-inclusion criteria : - Hypersensitivity to abiraterone acetate or enzalutamide - For patients candidate for abiraterone acetate, presence of severe hepatic insufficiency |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU | Amiens | |
| France | centre François Baclesse | Caen | |
| France | Institut régional du Cancer de Montpellier (ICM) | Montpellier | |
| France | Chu Rouen | Rouen | |
| France | Hôpital FOCH | Suresnes | |
| France | IGR | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse | National Cancer Institute, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires | 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer | ||
| Secondary | The quantitative score of cognitive functions by questionnaires | Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer | ||
| Secondary | the quantitative score of quality of life by questionnaires for evaluate impact of cognitive impairment on quality of life to treatment | Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer | ||
| Secondary | the quantitative score of anxiety/depression by questionnaires for evaluate impact of cognitive impairment | Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer | ||
| Secondary | the quantitative score of fatigue by questionnaires for evaluate impact of cognitive impairment | Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer | ||
| Secondary | the quantitative score of autonomy by geriatric evaluation for evaluate impact of cognitive impairment | Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer | ||
| Secondary | the quantitative score of observance of treatment by questionnaire | Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer |