Actively Recruiting
An Observational Prospective Study in France: Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Patients
Led by Janssen Cilag S.A.S. · Updated on 2026-06-05
270
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying how well men with metastatic hormone-sensitive prostate cancer (mHSPC) stick to their prescribed treatment with apalutamide during the first year of use. The study focuses on real-world treatment adherence and persistence, along with identifying risk factors for not following the treatment plan based on patient profiles and behaviors. This observational study is sponsored by Janssen Cilag S.A.S. and takes place in France. Participants diagnosed with mHSPC will start apalutamide treatment along with androgen-deprivation therapy (ADT) as decided by their physician. The study does not involve giving any treatments but follows patients from the start of apalutamide use (Month 0) through 12 months after the end of the study visit (Month 12). No placebo or additional interventions are administered. During the study, participants will complete adherence and quality-of-life questionnaires before starting apalutamide and at regular intervals. Researchers will monitor adherence using tools like the MARS-5 and SPUR adherence tool, track prostate-specific antigen (PSA) levels, and assess various clinical factors such as comorbidities, disease volume, and performance status. Data collection will also include demographic information, treatment changes, adverse events, and progression-free survival up to 12 months.
CONDITIONS
Brief 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 18 years or older
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- Documented metastatic hormone-sensitive prostate cancer (mHSPC)
- Agreed with treating physician to start apalutamide plus androgen-deprivation therapy (ADT) before study inclusion
- Able to understand the patient information and provided oral consent for data collection
- Baseline prostate-specific antigen (PSA) level collected before first apalutamide dose
- Willing to complete adherence and quality-of-life questionnaires during the study including before first apalutamide dose
You will not qualify if you...
- Previously received or currently receiving apalutamide, other androgen receptor pathway inhibitors, or chemotherapy for mHSPC
- Received investigational drugs or invasive investigational medical devices within 90 days before study start
- Currently in an interventional study for prostate cancer treatment
- Received ADT for mHSPC for more than 4 months before starting apalutamide
- Experienced disease progression under ADT 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants who start apalutamide treatment in routine clinical practice are observed without additional intervention for adherence and clinical outcomes.
Visits at baseline, Months 3, 6, 9, and 12
Trial Site Locations
Total: 1 location
1
Centre Francois Baclesse
Caen, France, 14076
Actively Recruiting
Research Team
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Study 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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