A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
Recruiting · NCT07451002 · Observational (researchers observe without assigning treatment) · Lead sponsor: Janssen Cilag S.A.S.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Centre Francois Baclesse - Caen, France