Condition: Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT07451002

Sponsor: Janssen Cilag S.A.S.

Phase:

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: Male

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

View trial on ClinicalTrials.gov