Clinical Trials in France / NCT07451002
Recruiting
Observational
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
NCT07451002 · tracked via the Priya Life Science France tracker
Condition(s) studied
Prostatic NeoplasmsMetastatic Hormone-sensitive Prostate Cancer
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Percentage of Participants With Adherence to Apalutamide at 12 Months — At 12 months
Adherent participants are defined as participants adherent to apalutamide at every visit until 12 months according to the Medication Adherence Report Scale (MARS-5). MARS-5 is a well-known participant-reported adherence measure (PRAM) consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence. - Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation — At 12 months
Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Francois Baclesse | Caen | France | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07451002 on ClinicalTrials.gov ↗ ← All trials in France