NCT07451002 A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
| NCT ID | NCT07451002 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Janssen Cilag S.A.S. |
| Condition | Prostatic Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 540 participants |
| Start Date | 2025-12-18 |
| Primary Completion | 2028-01-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 540 participants in total. It began in 2025-12-18 with a primary completion date of 2028-01-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Janssen-Cilag France Clinical Trial
STUDY DIRECTOR
Janssen-Cilag France
Frequently Asked Questions
Who can join the NCT07451002 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07451002 currently recruiting?
Yes, NCT07451002 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07451002 trial being conducted?
This trial is being conducted at Caen, France.
Who is sponsoring the NCT07451002 clinical trial?
NCT07451002 is sponsored by Janssen Cilag S.A.S.. The principal investigator is Janssen-Cilag France Clinical Trial at Janssen-Cilag France. The trial plans to enroll 540 participants.