Prospective Observational Evaluation of Quality of Life, Functional Status, and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer Undergoing Androgen Receptor Pathway Inhibitor Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Change From Baseline in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Total Score
研究概览
简要总结
This prospective observational study will evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) receiving androgen receptor pathway inhibitors (ARPIs) in addition to standard androgen deprivation therapy. ARPIs in this study include abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on local availability. A total of 102 patients will be enrolled from two academic oncology centers in Türkiye.
Participants will be assessed at baseline, 3 months, and 6 months using validated Turkish versions of established questionnaires: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI). Clinical parameters, ECOG performance status, routine laboratory results, and treatment-related adverse events will also be recorded.
The primary outcomes are longitudinal changes in FACT-Cog and FACT-F scores. Secondary outcomes include changes in depression, sleep quality, laboratory results, and adverse events. This study will provide real-world evidence on how ARPI therapy affects cognitive health and quality of life in patients with mHSPC.
详细描述
Metastatic hormone-sensitive prostate cancer (mHSPC) is a disease stage in which systemic treatment strategies significantly affect survival, functional status, and quality of life. The incorporation of androgen receptor pathway inhibitors (ARPIs) into clinical practice has improved oncological outcomes, yet their influence on cognitive function, fatigue, mood, and sleep requires further real-world investigation.
In this study, the term androgen receptor pathway inhibitors (ARPIs) refer to abiraterone acetate, apalutamide, enzalutamide, and darolutamide. While abiraterone, apalutamide, and enzalutamide are widely used in routine practice in Türkiye, darolutamide may also be included when accessible. All patients will receive ARPIs in combination with standard androgen deprivation therapy (ADT).
This prospective, multicenter, observational cohort study will enroll 102 patients with newly diagnosed mHSPC at Ankara Etlik City Hospital and Gazi University. Assessments will take place at baseline, 3 months, and 6 months.
Validated Turkish patient-reported outcome instruments will be applied:
FACT-Cog: score range 0-148; higher scores = better cognitive functioning.
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
- •Age ≥18 years
- •Histologically or cytologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC)
- •Planned initiation of androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, or enzalutamide) as part of routine clinical care
- •Ability to complete patient-reported outcome questionnaires (FACT-Cog, FACT-F, PHQ-9, PSQI)
- •Written informed consent obtained
排除标准
- •Prior systemic therapy for metastatic prostate cancer (except ≤3 months of ADT)
- •Known history of severe cognitive impairment that precludes completion of questionnaires
- •Concurrent active malignancy requiring systemic treatment
- •Inability to comply with study procedures or follow-up
- •Any condition judged by the investigator to compromise participation or data integrity
研究组 & 干预措施
Androgen Receptor Pathway Inhibitor Cohort
Men with metastatic hormone-sensitive prostate cancer receiving androgen receptor pathway inhibitors (abiraterone acetate, apalutamide, enzalutamide, or darolutamide) in combination with standard androgen deprivation therapy. Participants will be assessed at baseline, 3 months, and 6 months for quality of life, cognitive function, fatigue, depression, sleep quality, clinical parameters, and treatment-related adverse events.
干预措施: Androgen Receptor Pathway Inhibitors (ARPIs) (Drug)
结局指标
主要结局
Change From Baseline in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Total Score
时间窗: Baseline, 3 months, and 6 months after treatment initiation
FACT-Cog total score ranges from 0 to 148, with higher scores indicating better cognitive functioning. Both continuous change (follow-up minus baseline) and categorical decline (≥10-point decrease from baseline, indicating clinically meaningful cognitive deterioration) will be assessed.
Change From Baseline in Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Score
时间窗: Baseline, 3 months, and 6 months after treatment initiation
FACT-F total score ranges from 0 to 52, with higher scores indicating less fatigue burden (better status). Both continuous change and categorical threshold (FACT-F ≤34 = clinically significant fatigue) will be evaluated.
次要结局
- Change From Baseline in Liver Function Parameters(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Renal Function Parameters(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Electrolyte Levels(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Complete Blood Count (CBC)(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Electrolyte Levels(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Depression Score(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Liver Function Parameters(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Renal Function Parameters(Baseline, 3 months, and 6 months after treatment initiation)
- Change From Baseline in Complete Blood Count (CBC)(Baseline, 3 months, and 6 months after treatment initiation)
研究者
Galip Can Uyar
Medical Oncology Specialist
Ankara Etlik City Hospital