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Table 1 Study inclusion and exclusion criteria

From: Impact of new generation hormone-therapy on cognitive function in elderly patients treated for a metastatic prostate cancer: Cog-Pro trial protocol

  Patients of interest (metastatic CRPCa) Control patients (metastatic PCa) Healthy participants
Inclusion criteria 70-years old or more 70-years old or more 70-years old or more
Patient must have a metastatic CRPCa Patient with metastatic prostate cancer without resistance to castration Man with no history of cancer
Patient must have been already treated with first generation of ADT Patient must have already started a first generation of ADT at least since 3 months -
Patient must be candidate for a treatment by a NGHT (with abiraterone acetate or enzalutamide), in combination with ADT - -
Treatment with biphosphonates is authorized - -
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 not received chemotherapy except one line per Docetaxel for hormono-sensitive situation and which must be completed for a least 18 months before inclusion -
OMS 0–2 OMS 0–2 Health status consistent with the participation to the study
Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale ≤3) Patient must be asymptomatic or pauci-symptomatic (with pain control, Visual Analog Scale ≤3) -
No known brain metastasis No known brain metastasis -
At least on level 3 (end of primary schools) of the Barbizet scale At least on level 3 (end of primary schools) of the Barbizet scale At least on level 3 (end of primary schools) of the Barbizet scale
Exclusion criteria Neurological sequelae of traumatic brain injury, stroke, multiple sclerosis, epilepsy, neuro-degenerative disease…
Personality disorders and known progressive psychiatric disorder
Drug use and/or heavy drinking
Assessed to be unable or unwilling to comply with the requirements of the protocol
  1. Abbreviations: CRPCa castration-resistant prostate cancer, ADT androgen deprivation therapy, NGHT new generations of hormone-therapy