PROLONG (PRostateOLaparibONcombinationGcc) Study

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

• 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. [Time frame: 6 and 12 months]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• -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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07674121 · D0817R00131

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗