NCT07451002Recruiting
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 540 (estimated)
- First submitted
- 26 Jan 2026
- Start date
- 18 Dec 2025
- Primary completion date
- 3 Jan 2028
- Lead sponsor
- Janssen Cilag S.A.S.
- Diseases
- Prostate cancer
- NCT number
- NCT07451002
What you commit to
- Study type: Observational
- Planned participants: 540
- From 18 Dec 2025 to the primary completion date, 3 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre François Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.