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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