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A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
CompletedN/A
Sponsor: Janssen-Cilag Ltd.
Conditions: Metastatic Hormone-sensitive Prostate Cancer
Interventions: Apalutamide, Enzalutamide
Countries: Austria, France, Germany, Greece, Spain, United Kingdom
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).
Eligibility overview
Sex: MALE
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility criteria
Inclusion Criteria: * Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate * Must have documented metastatic hormone-sensitive prostate cancer (mHSPC) * Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy \[ADT\]) treatment, per the treating physician's decision, prior to enrollment into the study * Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements * Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide * Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide Exclusion Criteria: * 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) * Is currently receiving an active treatment for prostate cancer as part of an interventional study * Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment * Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation * Has received prior docetaxel for the treatment of mHSPC * Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
Locations (53)
- Vienna, Austria
- Wels, Austria
- Avignon, France
- Bordeaux, France
- Bordeaux, France
- Brest, France
- La Tronche, France
- Lyon, France
- Nancy, France
- Nîmes, France
- Paris, France
- Paris, France
- Pontoise, France
- Quint-Fonsegrives, France
- Saint-Grégoire, France
- Strasbourg, France
- Suresnes, France
- Toulouse, France
- Dierdorf, Germany
- Dresden, Germany
- Duisburg, Germany
- Gladenbach, Germany
- Hamburg, Germany
- Mainz, Germany
- Münster, Germany
- Regensburg, Germany
- Athens, Greece
- Athens, Greece
- Athens, Greece
- Athens, Greece
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