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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 January 2023
• Main ID: NCT02907372
• Date of registration: 26/07/2016
• Prospective Registration: Yes
• Primary sponsor: Centre Francois Baclesse
• Public title: Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer COG-PRO
• Scientific title: Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer
• Date of first enrolment: November 2016
• Target sample size: 163
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02907372
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

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



Age minimum: 70 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Metastatic Castration-resistant Prostate Cancer (CRPCa)

Intervention(s)

Other: neuropsychologic evaluation

Other: oncogeriatric evaluation

Primary Outcome(s)

The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires [Time Frame: 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

Secondary Outcome(s)

the quantitative score of fatigue by questionnaires for evaluate impact of cognitive impairment [Time Frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

the quantitative score of quality of life by questionnaires for evaluate impact of cognitive impairment on quality of life to treatment [Time Frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

the quantitative score of anxiety/depression by questionnaires for evaluate impact of cognitive impairment [Time Frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

The quantitative score of cognitive functions by questionnaires [Time Frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

the quantitative score of autonomy by geriatric evaluation for evaluate impact of cognitive impairment [Time Frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

the quantitative score of observance of treatment by questionnaire [Time Frame: Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer]

Secondary ID(s)

2016-001248-20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute, France