How well men with metastatic prostate cancer take apalutamide in France
Follows how consistently men with metastatic hormone-sensitive prostate cancer take apalutamide.
Plain-language title generated from the registry record
Registry title: A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Key facts
- Where
- Caen, FranceSee the site
Where in France
- Centre François BaclesseCaen, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Janssen Cilag S.A.S.
- Trial code
- NCT07451002
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France
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.
Inclusion: 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.
Exclusion: 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.