A Prospective Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC) in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,030
- 试验地点
- 148
- 主要终点
- Number of CRPC Treatment Patterns
研究概览
简要总结
The purpose of this study is to describe patterns of care in CRPC patients, as well as health-related quality of life (HRQoL) outcomes associated with CRPC and its management.
This study will also describe factors influencing treatment decisions including reason(s) for treatment choices and triggers for treatment changes for CRPC as well as describe clinical outcomes based on patient characteristics.
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
- •Patient Inclusion:
- •Patient may have M0 or M1 disease
- •Confirmed diagnosis of CRPC defined by both Testosterone at castrate levels, as evidenced by a serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) and Clear progressive disease, as evidenced by a minimum of two rising PSA levels measured at least 7 days apart or new clinical or imaging evidence of progressive metastatic disease
- •Initiating the first or second line treatment for CRPC: including anti- androgens, androgen synthesis inhibitors, chemotherapy, immunotherapy or radionuclide therapy. Previous first line CRPC treatments are limited to: First generation anti-androgens (bicalutamide, flutamide, or nilutamide) or Sipuleucel-T
- •Patients may be enrolled within 90 days from the time of decision to treat or within 90 days of treatment initiation.
- •Willing and able to complete periodic patient-reported outcome (PRO) questionnaires, with or without assistance
- •Estimated life expectancy of ≥ 6 months
- •Caregiver Inclusion:
- •Meets the definition of an unpaid relative or friend who helps the patient with his or her activities of daily living
- •Willing and able to complete caregiver-reported outcome questionnaires over the course of the patient's participation in the study
排除标准
- •Patient Exclusion:
- •Receiving concomitant treatment for other cancer (excluding basal cell carcinoma, squamous cell carcinoma and treatment for hormone sensitive prostate cancer) within 6 months prior to enrollment.
结局指标
主要结局
Number of CRPC Treatment Patterns
时间窗: Up to 6 years following enrollment onto the study
Treatment patterns will be described according to: The distribution and timing of disease assessment methods (PSA, other laboratory testing, imaging); Treatment settings; Physician referral patterns from urologist to oncologist (occurrence and timing of referrals) where applicable; CRPC treatments, including initial choices, sequencing and entry into interventional clinical trials
Health-related Quality of Life (HRQoL) as assessed by Modified Total Illness Burden Index (TIBI-CaP)
时间窗: Baseline
HRQoL as assessed by SF-12v2 Health Survey
时间窗: Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P)
时间窗: Baseline and up to 6 years approximately every 3-6 months
HRQoL as assessed by Brief Pain Inventory - Short Form (BPI-SF)
时间窗: Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC)
时间窗: Baseline and up to 6 years approximately every 3 months
HRQoL as assessed by Work Productivity and Activity Questionnaire: Specific Health Problem (WPAI-SHP)
时间窗: Baseline and up to 6 years approximately every 3-6 months
HRQoL as assessed by Service Satisfaction Scale for Cancer Care (SCA)
时间窗: Baseline and up to 6 years approximately every 3-6 months
次要结局
- Number of patients with Physician Factors for Treatment Decisions(Up to 6 years following enrollment onto the study)
- Number of patients with Clinical outcomes, including PSA values, clinical and/or radiologic evidence of disease progression and overall survival(Up to 6 years following enrollment onto the study)
- Number of patients with Prognostic factors (e.g., patient and disease characteristics) potentially related to select clinical outcomes and HRQoL(Up to 6 years following enrollment onto the study)