Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Janssen-Cilag Ltd.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
