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

About This Trial

  • This study looks at how consistently patients take a daily prescription medicine called apalutamide during their first year of treatment.
  • It is for men with advanced prostate cancer that still responds to hormone therapy who, along with their doctor, have already decided to start taking apalutamide for the first time.
  • Researchers want to understand everyday routines and personal challenges that might make it difficult for people to take their pills as prescribed.
  • Because this study tracks standard care rather than testing a brand-new drug, participating mainly involves answering regular questionnaires about your medication habits and your overall quality of life.

More Information

  • 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 Enroll

  • Age Range: 18 years and older
  • Gender: Male
  • Who This Trial is For: This study looks at how consistently patients take a daily prescription medicine called apalutamide during their first year of treatment.

Study Details

  • Start Date: December 18, 2025
  • Lead Sponsor: Janssen Cilag S.A.S.
Full 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 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
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