PROLONG (PRostateOLaparibONcombinationGcc) Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAstraZeneca
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
-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
Trial design
Treatments tested in this trial
- Olaparib and Abiraterone Combination
Treatment groups
75 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov