Actively Recruiting
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Led by Janssen Cilag S.A.S. · Updated on 2026-05-08
270
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male (based on chromosomal composition at birth) and aged greater than or equal to (≥) 18 years.
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- Documented metastatic hormone-sensitive prostate cancer (mHSPC).
- Agreed with the treating physician to start treatment with apalutamide plus androgen-deprivation therapy (ADT) according to current product guidelines before study inclusion.
- Able to understand the patient information sheet content and has provided oral consent for data collection.
- Baseline prostate-specific antigen (PSA) level collected before first administration of apalutamide.
- Agrees to complete adherence and quality-of-life questionnaires during the study, including before first apalutamide administration.
You will not qualify if you...
- Has already received or is currently receiving apalutamide or any other androgen receptor pathway inhibitor (ARPI) such as abiraterone acetate, darolutamide, or enzalutamide, or chemotherapy for mHSPC.
- Has received an investigational drug or invasive investigational medical device within 90 days before study start or data collection.
- Currently receiving active treatment for prostate cancer as part of an interventional study.
- Has received androgen-deprivation therapy (ADT) for mHSPC for more than 4 months before starting apalutamide.
- Experienced progression under ADT and became castration-resistant before starting apalutamide.
- Beneficiary of State Medical Aid (AME).
- Does not speak or read French.
- Under guardianship, curatorship, or judicial protection.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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