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

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

Recruiting
18 years and older
Male
Phase N/A

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Overview

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

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

Study details
    Prostatic Neoplasms
    Metastatic Hormone-sensitive Prostate Cancer

NCT07451002

Janssen Cilag S.A.S.

13 May 2026

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