NCT07451002招募中不适用
An OBServational Prospective Study in France: Adherence to APAlutamide in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in France
Janssen Cilag S.A.S.1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2025年12月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adherence to Apalutamide at 12 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Metastatic hormone-sensitive prostate cancer (mHSPC): Routine Clinical Practice Setting
Participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide (Month 0) in routine clinical practice and will be followed up until 12 months after end of study visit (Month 12). No intervention will be administered as a part of this study.
结局指标
主要结局
Percentage of Participants With Adherence to Apalutamide at 12 Months
时间窗: At 12 months
Adherent participants are defined as participants adherent to apalutamide at every visit until 12 months according to the Medication Adherence Report Scale (MARS-5). MARS-5 is a well-known participant-reported adherence measure (PRAM) consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
Number of Participants Reporting Change in Adherence According to MARS-5 by Apalutamide Formulation
时间窗: At 12 months
Participants with changes in adherence according to the MARS-5, by apalutamide formulation will be reported. MARS-5 is a well-known PRAM consisting of 5 items assessing the adherence behavior of a participant to a given medication with a 5-point scale, ranging from "always" to "never" (1-5 points). The scale total ranges from 5 (lowest adherence) to 25 points (maximal adherence). A higher score indicates more adherence.
次要结局
- Clinical Risk Factor Among Adherent and Non-adherent Participants: ECOG Status(Up to 12 months)
- Clinical Risk Factor Among Adherent and Non-adherent Participants: Comorbidities(Up to 12 months)
- Clinical Factors of Adherence at 12 Months: Disease Volume(At 12 months)
- Percentage of Adherent Participants at 3, 6, and 9 Months(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(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(Baseline, Months 3, 6, 9 and 12)
- Spearman Correlation Coefficients at Baseline and Month 12(At Baseline and Month 12)
- SPUR Global Risk Score at Baseline and Month 12(At Baseline and Month 12)
- Functional Assessment of Cancer Therapy- Prostate (FACT-P) Score(At Baseline, Months 3, 6, 9, 12)
- Change from Baseline in FACT-P Score at 3, 6 and 9 Months(Baseline, Months 3, 6, 9, 12)
- Demographics Characteristics of Participants: Age(Baseline)
- Demographics Characteristics of Participants: Socio-Professional Category(Baseline)
- Demographics Characteristics of Participants: G8 Geriatric Screening Score(Baseline)
- Prostate-Specific Antigen (PSA) Level at Androgen-Deprivation Therapy (ADT) Initiation(Up to 12 months)
- PSA Level at Baseline(At Baseline)
- Change from Baseline in PSA Levels(Baseline up to 12 months)
- Serum Testosterone at Baseline(At baseline)
- Time from Initial Diagnosis of Prostate Cancer to Metastatic Stage(Baseline up to 12 months)
- Type of Imaging Methods Used for Cancer Diagnostics(Baseline)
- Osteodensitometry Score(Baseline)
- Tumor assessment: Location of Metastases(Baseline)
- Number of Participants with >= 90% Decline in PSA Values (PSA 90) from Baseline(Baseline up to 12 months)
- Tumor assessment: Number of Lesions(Baseline)
- ECOG Performance Status(At Baseline)
- Number of Participants with History of Treatment for Prostate Cancer(Baseline)
- Number of Participants Reporting Concomitant Diseases(Baseline)
- Number of Participants With Vital Sign Assessments(Baseline)
- Number of Participants with Decrease in PSA Levels (PSA Halving-time)(Up to 12 months)
- Time from Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Diagnosis to Treatment Initiation(Baseline up to 12 months)
- Percentage of Participants Reaching Undetectable PSA(At Months 3,6,9,12)
- Percentage of Participants Reaching Ultralow (UL) PSA(At Months 3,6,9,12)
- Time to Undetectable PSA(Up to 12 months)
- Time to UL PSA(Up to 12 months)
- Number of Participants with Greater Than or Equal to (>=) 50% Decline in PSA Values (PSA 50) from Baseline(Baseline up to 12 months)
- Progression-Free Survival (PFS)(At Months 3,6,9,12)
- Number of Deaths(At Months 3,6,9,12)
- Number of Participants Reporting Change Since Baseline in Apalutamide and ADT Modalities(At Baseline, Months 3,6,9,12)
- Time from mHSPC Diagnosis to ADT Treatment Initiation(Baseline up to Month 12)
- Time Between ADT and Apalutamide Treatment Initiation(Baseline up to Month 12)
- Number of Participants with Apalutamide Treatment Discontinuation(At Months 3,6,9,12)
- Reasons for Discontinuation of Apalutamide Treatment(At Months 3,6,9,12)
- Time to Discontinuation of Apalutamide Treatment(At Months 3,6,9,12)
- Number of Participants Receiving Planned Subsequent Treatment for Prostate Cancer(At Months 3,6,9,12)
- Percentage of Participants who Consulted for Treatment(At Months 3,6,9,12)
- Percentage of Participants who Used Caregiver Support(At Months 3,6,9,12)
- Number of Participants Receiving Concomitant Treatments(At Baseline, Months 3,6,9,12)
- Number of Participants with a Change in Concomitant Treatments(At Months 3,6,9,12)
- Number of Participants Experiencing At Least One Adverse Event (AE)(At Months 3,6,9,12)
- Percentage of Undetectable PSA According to Adherence Levels(At Months 3,6,9,12)
- Percentage of UL PSA According to Adherence Levels(At Months 3,6,9,12)
- Number of Participants with PSA 50 Response According to Adherence Levels(At Months 3,6,9, and 12)
- Number of Participants with PSA 90 Response According to Adherence Levels(At Months 3,6,9, and 12)
- Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Concomitant Treatments(Up to 12 months)
- Clinical Risk Factor Among Adherent and Non-adherent Participants: Prostate Specific Antigen (PSA) Rate(Up to 12 months)
- Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Socio-professional Category(Up to 12 months)
- Clinical Risk Factor Among Adherent and Non-adherent Participants: Number of Participants Reporting the Use of Disease Specialized Consultations(Up to 12 months)
研究者
研究点 (1)
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