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OBSAPA

Evaluation de l’observance au traitement par apalutamide chez des patients atteints d’un cancer de la prostate métastatique hormonosensible (CPHSm) en France

Critères d'inclusion :

1. Male (according to their chromosomal composition at birth) and aged ≥18 years.


2. Must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate.


3. Must have documented mHSPC.


4. Must have agreed with the treating physician the initiation of apalutamide (plus ADT) treatment in line with current Summary of Product Characteristics, per the treating physician’s decision, prior to enrollment into the study.


5. Able to understand the content of the Patient Information Notice and has given their non-objection to the collection of their data.


6. Must have baseline PSA captured before the first administration of apalutamide.


7. Must agree to complete PRAMs and PROs during the study, including at baseline before the first administration of apalutamide.

Critères de non inclusion :

1. Has already received or is currently receiving apalutamide, or any other ARPI (including but not limited to abiraterone acetate, darolutamide and enzalutamide) or chemotherapy for mHSPC.


2. Has received an investigational medicinal product (including investigational vaccines) or used an invasive investigational medical device within 90 days before the start of the study or the first data collection time point.


3. Is currently receiving an active treatment for prostate cancer as part of an interventional study.


4. Has received ADT treatment for mHSPC for more than 4 months prior to apalutamide treatment initiation.


5. Has progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide treatment.


6. Benefiting from State Medical Aid (aide médicale de l'État [AME]) (14).


7. Not speaking/reading French.

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