A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France

NCT07451002 | Recruiting

• 1 other identifier: 56021927MPC4009
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Metastatic Hormone-sensitive Prostate Cancer

Keywords

Apalutamide; mHSPC

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Adherence to Apalutamide at 12 Months

  Adherent participants are defined as participants adherent to apalutamide at every visit until 12 months according to the Medication Adherence Report Scale (MARS-5). MARS-5 is a well-known participant-reported adherence measure (PRAM) consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.

  At 12 months

• Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation

  Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.

  At 12 months

Secondary Outcomes (56)

• Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status

  Up to 12 months

• Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities

  Up to 12 months

• Clinical Factors of Adherence at 12 Months: Disease Volume

  At 12 months

• Percentage of Adherent Participants at 3, 6, and 9 Months

  At 3,6,9 months

• Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation at 3, 6 and 9 Months

  At 3, 6 and 9 months

Study Arms (1)

Metastatic hormone-sensitive prostate cancer (mHSPC): Routine Clinical Practice Setting

Participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide (Month 0) in routine clinical practice and will be followed up until 12 months after end of study visit (Month 12). No intervention will be administered as a part of this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult male (according to their chromosomal composition at birth) participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Cilag S.A.S.: lead

Study Sites (1)

Centre Francois Baclesse

Caen, 14076, France

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen-Cilag France Clinical Trial

  Janssen-Cilag France

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: March 5, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): September 18, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)