Prospective, Multi-Country, Observational Study of Clinical Outcomes for Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With ADT Plus Apalutamide or Enzalutamide Under Routine Clinical Practice (ArtemisPRO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 505
- 试验地点
- 93
- 主要终点
- Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
研究概览
简要总结
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).
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
- •Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate
- •Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)
- •Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy [ADT]) treatment, per the treating physician's decision, prior to enrollment into the study
- •Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- •Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide
- •Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide
排除标准
- •Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide)
- •Is currently receiving an active treatment for prostate cancer as part of an interventional study
- •Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment
- •Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation
- •Has received prior docetaxel for the treatment of mHSPC
- •Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
研究组 & 干预措施
Enzalutamide Plus Androgen Deprivation Therapy (ADT)
Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
干预措施: Enzalutamide (Drug)
Apalutamide Plus Androgen Deprivation Therapy (ADT)
Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
干预措施: Apalutamide (Drug)
结局指标
主要结局
Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3
时间窗: At month 3
Percentage of participants with PSA level less than (\<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.
Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire
时间窗: Up to 30 Months
Cognitive function of the participants will be measured by the partial FACT-Cog (Version 3) questionnaire. The FACT-Cog score ranges from scale 0-148. The higher the total score, the better the cognitive function.
Health-Related Quality of Life (HRQoL) as Assessed by Partial European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire
时间窗: Up to 30 Months
HRQoL of the participants will be assessed as partial EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.
Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire
时间窗: Up to 30 Months
Participant fatigue will be assessed by the BFI-SF questionnaire. The BFI-SF score range from scale 0-10. Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire
时间窗: Up to 30 Months
PSA anxiety of the participant will be assessed by the MAX-PC questionnaire. The MAX-PC total score ranges from scale 0 to 54. The MAX-PC is divided into three subscales: a) prostate cancer anxiety (PCA) range from 0 to 33, b) Prostate-Specific Antigen Anxiety (PSAA) ranges from 0 to 9, and c) fear of recurrence (FOR) ranges from 0 to 12.
次要结局
未报告次要终点