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Идёт набор NCT07451002

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

— Наблюдательное Prostatic Neoplasms Metastatic Hormone-sensitive Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Prostatic Neoplasms, Metastatic Hormone-sensitive Prostate Cancer. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Первичные конечные точки

  • Percentage of Participants With Adherence to Apalutamide at 12 Months [Срок оценки: At 12 months]
  • Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation [Срок оценки: At 12 months]
Вторичные конечные точки (12)
  • Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status [Срок оценки: Up to 12 months]
  • Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities [Срок оценки: Up to 12 months]
  • Clinical Factors of Adherence at 12 Months: Disease Volume [Срок оценки: At 12 months]
  • Percentage of Adherent Participants at 3, 6, and 9 Months [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, Months 3, 6, 9 and 12]
  • Spearman Correlation Coefficients at Baseline and Month 12 [Срок оценки: At Baseline and Month 12]
  • SPUR Global Risk Score at Baseline and Month 12 [Срок оценки: At Baseline and Month 12]
  • Functional Assessment of Cancer Therapy- Prostate (FACT-P) Score [Срок оценки: At Baseline, Months 3, 6, 9, 12]
  • Change from Baseline in FACT-P Score at 3, 6 and 9 Months [Срок оценки: Baseline, Months 3, 6, 9, 12]
  • Demographics Characteristics of Participants: Age [Срок оценки: Baseline]
  • Demographics Characteristics of Participants: Socio-Professional Category [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Centre Francois Baclesse — Caen

Идентификаторы

NCT: NCT07451002 · 56021927MPC4009

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗