PROLONG (PRostateOLaparibONcombinationGcc) Study

N/ANot Yet RecruitingNCT07674121

AstraZeneca75 enrolled

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Interventions

Olaparib and Abiraterone CombinationDRUG

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 months

Secondary Outcomes

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 months

Describe patient demographics: age in years

Patient demographics: age collected in years