A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France
An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France
Sponsor: Janssen Cilag S.A.S.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants With Adherence to Apalutamide at 12 Months
Time frame: At 12 months
Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation
Time frame: At 12 months
Secondary Endpoints
Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status
Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities
Clinical Factors of Adherence at 12 Months: Disease Volume
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 apalutami…
Read full criteria on CT.gov →✦ Analyst Commentary
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