Tracking apalutamide use in men with metastatic hormone-sensitive prostate cancer in France
An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France
This project will see if men with metastatic hormone-sensitive prostate cancer in France take apalutamide as prescribed during their first year of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Janssen Cilag S.A.S. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Caen) |
| Trial ID | NCT07451002 on ClinicalTrials.gov |
What this trial studies
This is an observational, real-world study that follows men who start apalutamide plus androgen-deprivation therapy for metastatic hormone-sensitive prostate cancer. Participants are enrolled before their first dose and must have a baseline PSA measurement. The study collects self-reported adherence and quality-of-life questionnaires over the first year and documents treatment persistence. Analysis will describe adherence rates and identify patient characteristics and behaviors associated with non-adherence, without altering clinical care.
Who should consider this trial
Good fit: Men aged 18 or older with histologically confirmed prostate adenocarcinoma and documented metastatic hormone-sensitive disease who have agreed with their physician to start apalutamide plus ADT, can provide a baseline PSA, and can complete study questionnaires.
Not a fit: Patients not starting apalutamide, those with non-metastatic disease, people unable or unwilling to complete questionnaires, or those treated outside participating French sites are unlikely to gain direct benefit from this study.
Why it matters
Potential benefit: If successful, the results could help clinicians spot patients at risk of poor adherence and design support measures to keep men on apalutamide longer.
How similar studies have performed: Real-world adherence studies of oral prostate cancer therapies have reported variable adherence and identified risk factors, but adherence-specific data for apalutamide in mHSPC are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: * 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 this trial is running
Caen
- Centre Francois Baclesse — Caen, France (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.