Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07451002
Eligibility 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT07451002
Study Brief:
Protocol Section:
NCT07451002