PROLONG (PRostateOLaparibONcombinationGcc) Study

Официальное название

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

Обзор

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).

Вмешательства

• Препарат Olaparib and Abiraterone Combination
  Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients

Первичные конечные точки

• 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. [Срок оценки: 6 and 12 months]

Вторичные конечные точки (12)

• Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months. [Срок оценки: 12 months]
• Describe patient demographics: age in years [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient demographics: sex [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient demographics: Body mass index (BMI) [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient clinical characteristics at baseline: Gleason score [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient clinical characteristics at baseline: metastasis site(s) at baseline [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe patient clinical characteristics at baseline: baseline serum PSA [Срок оценки: Collected at Baseline on the day of the first patient visit]
• Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies [Срок оценки: 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). [Срок оценки: Collected at Baseline on the day of the first patient visit]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• -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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07674121 · D0817R00131

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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