A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Recruiting now
Conditions studied: Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT07451002
- Run by
- Janssen Cilag S.A.S.
- People needed
- 540
- Starts
- 2025-12-18
- Expected to finish
- 2028-09-18
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Able to understand the content of the patient information sheet and has provided oral consent for data collection. Has received the information sheet and has not objected to data collection
- Must have a baseline prostate-specific antigen (PSA) level collected prior to the first administration of apalutamide.
- Must agree to complete adherence and quality-of-life questionnaires during the study, including before the first administration of apalutamide
You may not qualify if…
- 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
- Has experienced progression under ADT (and thus became castration-resistant) before starting apalutamide treatment
- Beneficiary of State Medical Aid [AME]
- Does not speak/read French
- Under guardianship or curatorship
- Under judicial protection
Where it is running
- Centre Francois Baclesse — Caen, France (enrolling)
Full record on ClinicalTrials.gov
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