PROLONG (PRostateOLaparibONcombinationGcc) Study (PROLONG)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
• Intervention / Treatment: Drug: Olaparib and Abiraterone Combination

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective Pathway; 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)	Drug: Olaparib and Abiraterone Combination; Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients
Retrospective Pathway; 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.	Drug: Olaparib and Abiraterone Combination; Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients
Ambispective Pathway; Enrollment of eligible patients with NHA pre-exposed mCRPC who had already initiated first-line Olaparib + Abiraterone in routine clinical practice up to 12 months before baseline and consent. Primary Follow-Up Period (12 months) and Exploratory Follow-Up Period (optional, up to 12 additional months)	Drug: Olaparib and Abiraterone Combination; Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Describe patient demographics: age in years	Patient demographics: age collected in years	Collected at Baseline on the day of the first patient visit
Describe patient demographics: sex	Patient demographics: sex collected as male or female	Collected at Baseline on the day of the first patient visit
Describe patient demographics: Body mass index (BMI)	Patient demographics: Body mass index (BMI) collected in kg/m 2	Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Gleason score	Patient Gleason score	Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status	Patient Eastern Cooperative Oncology Group (ECOG) performance status	Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: metastasis site(s) at baseline	metastasis site(s) at baseline	Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status	Patient Homologous Recombination Repair (HRR) mutation status	Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status	Patient Breast Cancer Gene (BRCA) mutation status	Collected at Baseline on the day of the first patient visit
Describe patient clinical characteristics at baseline: baseline serum PSA	Patient baseline serum PSA	Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies	Describe the Duration of previous therapies by collecting start and end date	Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).	Descriptive characterization of prior treatment patterns, including: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).	Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination.	Descriptive characterization of prior treatment patterns, including: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).; Duration of previous therapies.	Collected at Baseline on the day of the first patient visit
Assess real-world progression free survival (rwPFS) using data collected at 12 months.	• Real-world progression-free survival (rwPFS), defined as the time from initiation of Olaparib + Abiraterone therapy (index date) until the earliest record of disease progression or death due to any cause, with progression determined as per routine practice, by physicians' assessments.	12 months
Assess real-world progression free survival (rwPFS) using data collected at 12 months.	description of progression will be collected,	12 months

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Olaparib and Abiraterone
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; olaparib
• Other Study ID Numbers: D0817R00131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No