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
This trial does not accept healthy volunteersQualifiers
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 population
The study population will consist of adult male patients (≥18 years) diagnosed with mCRPC who initiate first-line treatment with Olaparib in combination with Abiraterone in routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Olaparib and Abiraterone Combination
DrugObserving the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Prospective Pathway1 intervention
Group B: Retrospective Pathway1 intervention
Group C: Ambispective Pathway1 intervention
Trial outcomes
Primary outcomes
1
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 to treatment discontinuation (TTD) or death (event-free rate) at 6 and 12 months of treatment, defined as the time from initiation of Olaparib + Abiraterone therapy (index date) until the end date of therapy or death due to any cause.
Time frame
6 and 12 monthsSecondary outcomes
1
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Time to first subsequent therapy (TFST), defined as the time from Olaparib + Abiraterone therapy (index date) initiation to the earlier of the first subsequent anticancer therapy start date following olaparib discontinuation due to any cause.
Time frame
12 months2
Describe patient demographics: age in years
Patient demographics: age collected in years
Time frame
Collected at Baseline on the day of the first patient visit3
Describe patient demographics: sex
Patient demographics: sex collected as male or female
Time frame
Collected at Baseline on the day of the first patient visit4
Describe patient demographics: Body mass index (BMI)
Patient demographics: Body mass index (BMI) collected in kg/m 2
Time frame
Collected at Baseline on the day of the first patient visitLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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