Clinical trial · Observational
PROLONG (PRostateOLaparibONcombinationGcc) Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olaparib and Abiraterone Combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Prospective Pathway
- description
- 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)
- interventionNames
- Drug: Olaparib and Abiraterone Combination
- label
- Retrospective Pathway
- description
- 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.
- interventionNames
- Drug: Olaparib and Abiraterone Combination
- label
- Ambispective Pathway
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available