Non-Interventional, Observational, Retrospective and Prospective, Single- Arm Study to Assess the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA Pre-exposed mCRPC Patients in the GCC Region
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AstraZeneca
- 入组人数
- 75
- 主要终点
- Evaluate the time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months in 1L NHA pre-exposed mCRPC patients treated with Olaparib + Abiraterone.
研究概览
简要总结
The study will generate regionally relevant data to inform clinical practice, support treatment guidelines, and potentially contribute to supportive evidence for health authority discussions or scientific publications. This aligns with AstraZeneca's strategic goal of expanding the real-world evidence (RWE) base for Olaparib in diverse populations and practice settings. The study also complements the strategic priorities and focus areas, as well as strengthening AstraZeneca's leadership position in the management of prostate cancer and establishing the intensification therapy of Poly (ADP-ribose) Polymerase Inhibitor (PARPi) combination in metastatic castration-resistant prostate cancer (mCRPC) with previous exposure to a novel hormonal agent (NHA) for current and future medications (a next-generation PARPi).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adult male patients (age ≥18 years)
- •Documented histopathology or cytopathology of metastatic prostate adenocarcinoma
- •Confirmed castration-resistant status, defined as disease progression despite castrate levels of serum testosterone (<50 ng/dL or <1.7 nmol/L), as demonstrated by radiographic progression, PSA progression, or symptomatic progression
- •Prior exposure to an NHA in earlier settings.
- •Planned or prior initiation of Olaparib + Abiraterone in the 1st line mCRPC setting as per routine clinical practice.
- •Patients who are willing and able to sign an informed consent and are either currently receiving or are planned to initiate Olaparib + Abiraterone per routine clinical practice.
排除标准
- •-Prior exposure to a Poly (ADP-ribose) Polymerase Inhibitor (PARPi), including Olaparib, Rucaparib, Niraparib, or Talazoparib.
- •Patients who received or progressed on abiraterone in previous lines of treatment before mCRPC diagnosis (e.g., in metastatic hormone-sensitive prostate cancer [mHSPC]).
- •Participation in an investigational clinical trial with another prostate cancer therapy within 30 days prior to Olaparib initiation.
- •Life expectancy <3 months (unrelated to mCRPC) that could interfere with study outcomes
- •Known hypersensitivity to Olaparib, Abiraterone, or their excipients.
- •Uncontrolled medical conditions that may compromise participation or data interpretation, in the opinion of the Investigator (e.g., severe hepatic impairment, active infections).
- •Any psychiatric or cognitive conditions that may interfere with the patient's ability to consent or comply with study procedures.
研究组 & 干预措施
Prospective Pathway
Enrollment of eligible patients with NHA pre-exposed mCRPC initiating first-line Olaparib + Abiraterone at the time of consent, and were scheduled to start treatment in routine clinical practice. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months)
干预措施: Olaparib and Abiraterone Combination (Drug)
Retrospective Pathway
Enrollment of eligible patients with NHA pre-exposed mCRPC who had initiated first-line Olaparib + Abiraterone in routine clinical practice and had already discontinued the regimen prior to enrollment. Clinical data will be collected retrospectively from the index date (treatment initiation) through treatment discontinuation and up to baseline from electronic medical records (EMRs). No prospective follow up beyond baseline is planned for this pathway.
干预措施: Olaparib and Abiraterone Combination (Drug)
Ambispective Pathway
Enrollment of eligible patients with NHA pre-exposed mCRPC who had already initiated first-line Olaparib + Abiraterone in routine clinical practice up to 12 months before baseline and consent. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months)
干预措施: Olaparib and Abiraterone Combination (Drug)
结局指标
主要结局
Evaluate the time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months in 1L NHA pre-exposed mCRPC patients treated with Olaparib + Abiraterone.
时间窗: 6 and 12 months
Time to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months of treatment, defined as the time from initiation of Olaparib + Abiraterone therapy (index date) until the end date of therapy or death due to any cause.
次要结局
- Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.(12 months)
- Describe patient demographics: age in years(Collected at Baseline on the day of the first patient visit)
- Describe patient demographics: sex(Collected at Baseline on the day of the first patient visit)
- Describe patient demographics: Body mass index (BMI)(Collected at Baseline on the day of the first patient visit)
- Describe patient clinical characteristics at baseline: Gleason score(Collected at Baseline on the day of the first patient visit)
- Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status(Collected at Baseline on the day of the first patient visit)
- Describe patient clinical characteristics at baseline: metastasis site(s) at baseline(Collected at Baseline on the day of the first patient visit)
- Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status(Collected at Baseline on the day of the first patient visit)
- Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status(Collected at Baseline on the day of the first patient visit)
- Describe patient clinical characteristics at baseline: baseline serum PSA(Collected at Baseline on the day of the first patient visit)
- Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies(Collected at Baseline on the day of the first patient visit)
- Describe treatment patterns before the Olaparib + Abiraterone combination: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).(Collected at Baseline on the day of the first patient visit)
- Describe treatment patterns before the Olaparib + Abiraterone combination.(Collected at Baseline on the day of the first patient visit)
- Assess real-world progression free survival (rwPFS) using data collected at 12 months.(12 months)