PROLONG (PRostateOLaparibONcombinationGcc) Study

NCT07674121 | Not Yet Recruiting FDA Drug

• 1 other identifier: D0817R00131
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Keywords

Prostate Cancer; Olaparib and Abiraterone

Outcome Measures

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.

  6 and 12 months

Secondary Outcomes (15)

• Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.

  12 months

• Describe patient demographics: age in years

  Collected at Baseline on the day of the first patient visit

• Describe patient demographics: sex

  Collected at Baseline on the day of the first patient visit

• Describe patient demographics: Body mass index (BMI)

  Collected at Baseline on the day of the first patient visit

• Describe patient clinical characteristics at baseline: Gleason score

  Collected at Baseline on the day of the first patient visit

Study Arms (3)

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

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

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

Interventions

Olaparib and Abiraterone Combination DRUG

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

Ambispective Pathway; Prospective Pathway; Retrospective Pathway

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adult male patients (age ≥18 years) with Documented diagnosis of metastatic castration-resistant prostate adenocarcinoma
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

olaparib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 29, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• 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
• 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