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NCT07451002RECRUITING

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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Key Facts

Study type
OBSERVATIONAL
Conditions
Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
Interventions
Enrollment
270 participants
Primary completion
Jan 2028
Study completion
Jan 2028
First posted
Mar 2026
Last updated
May 2026

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

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov