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NCT Number: NCT07674121

PROLONG (PRostateOLaparibONcombinationGcc) Study

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).

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olaparib and Abiraterone Combination

Drug

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

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 frame: 6 and 12 months

    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.

Secondary outcomes

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

    Time frame: 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.

  2. Describe patient demographics: age in years

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient demographics: age collected in years

  3. Describe patient demographics: sex

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient demographics: sex collected as male or female

  4. Describe patient demographics: Body mass index (BMI)

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient demographics: Body mass index (BMI) collected in kg/m 2

  5. Describe patient clinical characteristics at baseline: Gleason score

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient Gleason score

  6. Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient Eastern Cooperative Oncology Group (ECOG) performance status

  7. Describe patient clinical characteristics at baseline: metastasis site(s) at baseline

    Time frame: Collected at Baseline on the day of the first patient visit

    metastasis site(s) at baseline

  8. Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient Homologous Recombination Repair (HRR) mutation status

  9. Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient Breast Cancer Gene (BRCA) mutation status

  10. Describe patient clinical characteristics at baseline: baseline serum PSA

    Time frame: Collected at Baseline on the day of the first patient visit

    Patient baseline serum PSA

  11. Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies

    Time frame: Collected at Baseline on the day of the first patient visit

    Describe the Duration of previous therapies by collecting start and end date

  12. Describe treatment patterns before the Olaparib + Abiraterone combination: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).

    Time frame: Collected at Baseline on the day of the first patient visit

    Descriptive characterization of prior treatment patterns, including: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).

  13. Describe treatment patterns before the Olaparib + Abiraterone combination.

    Time frame: Collected at Baseline on the day of the first patient visit

    • Descriptive characterization of prior treatment patterns, including: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others).
    • Duration of previous therapies.

  14. Assess real-world progression free survival (rwPFS) using data collected at 12 months.

    Time frame: 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.

  15. Assess real-world progression free survival (rwPFS) using data collected at 12 months.

    Time frame: 12 months

    description of progression will be collected,

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: PROLONG

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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