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ARTEMIS pro

Étude prospective, internationale, observationnelle des résultats cliniques chez
des patients atteints d’un cancer de la prostate métastatique hormonodépendant traités par
privation androgénique (ADT) plus apalutamide ou enzalutamide dans le cadre de la pratique
clinique de référence

Critères d'inclusion :

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


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

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3. Must have documented mHSPC


4. Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus ADT) treatment, per the treating physician’s decision, prior to enrollment into the study


5. Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ICF allowing data collection and source data verification in accordance with local requirements


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


7. Must agree to complete PROs during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide

Critères de non inclusion :

1. Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide)


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


3. Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment


4. Has received ADT treatment for more than 2 months prior to apalutamide or enzalutamide treatment initiation


5. Has received prior immediate docetaxel for the treatment of mHSPC


6. Patient is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide

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