Impact of new generation hormono-therapy on cognitive functions in elderly patients treated for a metastatic prostate cancer

Phase 1

• Conditions: Metastatic prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001248-20-FR
• Lead Sponsor: Centre François Baclesse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 222

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
-OMS 0-2
-Patient must have not received chemotherapy,
-Patient must have been already treated with first generation of ADT (androgen deprivation therapy)
-Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale - VAS = 3)
-Patient must be candidate for a treatment by a new generation hormono-therapy (with abiraterone acetate or enzalutamide), in combination with ADT

For control group of patients :
-Patient with metastatic prostate cancer without resistance to castration
-Patient must be 70 years and more
-OMS 0-2
-Patient must have not received chemotherapy,
-Patient must have already started the first generation of ADT at least since 3 months

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 222

Exclusion Criteria

For all participants (group of patients of interest, control group of patients and group of healthy volunteers):
-Neurological history (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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified