Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer (COG-PRO)

This is an interventional diagnostic trial for Metastatic Castration-resistant Prostate Cancer (CRPCa) focused on measuring cognitive dysfunctions, cognitive complaints, metastatic prostate cancer, new generations of hormone-therapy Read More

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