Tracking apalutamide use in men with metastatic hormone-sensitive prostate cancer in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Francois Baclesse
  Caen, France Recruiting

Study contacts

• Study coordinator: Study Contact
• Email: Participate-In-This-Study1@its.jnj.com
• Phone: 844-434-4210

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.