A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Partic… (NCT07451002) | Clinical Trial Compass
RecruitingNot Applicable
A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
France270 participantsStarted 2025-12-18
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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 interve…
What they're measuring
1
Percentage of Participants With Adherence to Apalutamide at 12 Months
Timeframe: At 12 months
2
Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation