Clinical trial · Interventional
Impact of New Generation Hormono-therapy on Cognitive Functions in Elderly Patients Treated for a Metastatic Prostate Cancer
NCT02907372CI-TRIAL-00063149COG-PROcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer (CRPCa) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neuropsychologic evaluation | Other | — | UNRESOLVED |
| oncogeriatric evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- cognitive tests
- interventionNames
- Other: neuropsychologic evaluation
- Other: oncogeriatric evaluation
Primary outcomes (1)
- measure
- The proportion of elderly patients who will experience a decline in cognitive performances (at least for one cognitive function) by questionnaires
- timeFrame
- 3 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
Secondary outcomes (6)
- measure
- The quantitative score of cognitive functions by questionnaires
- timeFrame
- Within 12 months after initiation of treatment by new generation hormono-therapies for a metastatic castration-resistant prostate cancer
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLange M, Laviec H, Castel H, Heutte N, Leconte A, Leger I, Giffard B, Capel A, Dubois M, Clarisse B, Coquan E, Di Fiore F, Gouerant S, Bartelemy P, Pierard L, Fizazi K, Joly F. Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol. BMC Cancer. 2017 Aug 16;17(1):549. doi: 10.1186/s12885-017-3534-8. PMID 28814281