Actively Recruiting

Age: 18Years +
MALE
NCT07451002

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

Led by Janssen Cilag S.A.S. · Updated on 2026-05-08

270

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male (based on chromosomal composition at birth) and aged greater than or equal to (≥) 18 years.
  • Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
  • Documented metastatic hormone-sensitive prostate cancer (mHSPC).
  • Agreed with the treating physician to start treatment with apalutamide plus androgen-deprivation therapy (ADT) according to current product guidelines before study inclusion.
  • Able to understand the patient information sheet content and has provided oral consent for data collection.
  • Baseline prostate-specific antigen (PSA) level collected before first administration of apalutamide.
  • Agrees to complete adherence and quality-of-life questionnaires during the study, including before first apalutamide administration.
Not Eligible

You will not qualify if you...

  • Has already received or is currently receiving apalutamide or any other androgen receptor pathway inhibitor (ARPI) such as abiraterone acetate, darolutamide, or enzalutamide, or chemotherapy for mHSPC.
  • Has received an investigational drug or invasive investigational medical device within 90 days before study start or data collection.
  • Currently receiving active treatment for prostate cancer as part of an interventional study.
  • Has received androgen-deprivation therapy (ADT) for mHSPC for more than 4 months before starting apalutamide.
  • Experienced progression under ADT and became castration-resistant before starting apalutamide.
  • Beneficiary of State Medical Aid (AME).
  • Does not speak or read French.
  • Under guardianship, curatorship, or judicial protection.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Francois Baclesse

Caen, France, 14076

Actively Recruiting

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Research Team

S

Study Contact

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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