NCT07674121Not yet recruiting
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 · Last updated 29 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 30 Jun 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Prostate cancer
- NCT number
- NCT07674121
What you commit to
- Study type: Observational
- Planned participants: 75
- From 30 Jun 2026 to the primary completion date, 30 Sept 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- -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.
Other illness
- 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.
Other
- Life expectancy \<3 months (unrelated to mCRPC) that could interfere with study outcomes
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.