A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorJanssen Cilag S.A.S.
About this trial
This study aims to explore the real-world treatment adherence, persistence of apalutamide, and assess the risk of non-adherence according to the participant's profile and behavior of metastatic hormone-sensitive prostate cancer (mHSPC) participants treated with apalutamide during the first year of continued treatment.
Eligibility criteria
Qualifiers
Male (based on chromosomal composition at birth) and aged greater than or equal to (>=) 18 years.
Must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)
Must have agreed with the treating physician to initiate treatment with apalutamide (plus androgen-deprivation therapy [ADT]) in accordance with the current product characteristics summary, based on the physician's decision, prior to study inclusion
Disqualifiers
Has already received or is currently receiving apalutamide, or any other androgen receptor pathway inhibitor (ARPI; including but not limited to abiraterone acetate, darolutamide, and enzalutamide) or chemotherapy for mHSPC
Has received an investigational drug (including vaccines) or used an invasive investigational medical device within 90 days prior to study start or data collection
Is currently receiving active treatment for prostate cancer as part of an interventional study
Has received ADT for mHSPC for more than 4 months prior to starting apalutamide treatment
Trial design
Treatments tested in this trial
- Not listed
Trial groups
270 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov