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Completed
NCT05901649
A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
Conditions: Metastatic Hormone-sensitive Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 505
Sponsor: Janssen-Cilag Ltd.
Location: Akh Wien Vienna
Summary
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 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
Source: ClinicalTrials.gov (NCT05901649). StuddyBuddy aggregates publicly available trial information.