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Recruiting NCT07451002

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

— Observational Prostatic Neoplasms Metastatic Hormone-sensitive Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France

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.

Primary outcome measures

  • 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 outcome measures (12)
  • Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status [Time frame: Up to 12 months]
  • Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities [Time frame: Up to 12 months]
  • Clinical Factors of Adherence at 12 Months: Disease Volume [Time frame: At 12 months]
  • Percentage of Adherent Participants at 3, 6, and 9 Months [Time frame: 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 [Time frame: At 3, 6 and 9 months]
  • Number of Participants with Risk of Non-Adherence as per Social, Psychological, Usage and Rational (SPUR) Factors as per SPUR Adherence Tool [Time frame: Baseline, Months 3, 6, 9 and 12]
  • Spearman Correlation Coefficients at Baseline and Month 12 [Time frame: At Baseline and Month 12]
  • SPUR Global Risk Score at Baseline and Month 12 [Time frame: At Baseline and Month 12]
  • Functional Assessment of Cancer Therapy- Prostate (FACT-P) Score [Time frame: At Baseline, Months 3, 6, 9, 12]
  • Change from Baseline in FACT-P Score at 3, 6 and 9 Months [Time frame: Baseline, Months 3, 6, 9, 12]
  • Demographics Characteristics of Participants: Age [Time frame: Baseline]
  • Demographics Characteristics of Participants: Socio-Professional Category [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Centre Francois Baclesse — Caen

Identifiers

NCT: NCT07451002 · 56021927MPC4009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗