A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
Prospective, Multi-Country, Observational Study of Clinical Outcomes for Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT Plus Apalutamide or Enzalutamide Under Routine Clinical Practice (ArtemisPRO)
Sponsor: Janssen-Cilag Ltd.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
Time frame: At month 3
Health-Related Quality of Life (HRQoL) as Assessed by Partial European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire
Time frame: Up to 30 Months
Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire
Time frame: Up to 30 Months
Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire
Time frame: Up to 30 Months
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:…
Read full criteria on CT.gov →✦ Analyst Commentary
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