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PROLONG (PRostateOLaparibONcombinationGcc) Study (PROLONG)

25. Juni 2026 aktualisiert von: AstraZeneca

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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

75

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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)
Arzneimittel: 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.
Arzneimittel: 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)
Arzneimittel: Olaparib and Abiraterone Combination
Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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.
6 and 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Zeitfenster: 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
Zeitfenster: Collected at Baseline on the day of the first patient visit
Patient demographics: age collected in years
Collected at Baseline on the day of the first patient visit
Describe patient demographics: sex
Zeitfenster: Collected at Baseline on the day of the first patient visit
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)
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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
Zeitfenster: Collected at Baseline on the day of the first patient visit
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).
Zeitfenster: 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).
Collected at Baseline on the day of the first patient visit
Describe treatment patterns before the Olaparib + Abiraterone combination.
Zeitfenster: 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.
Collected at Baseline on the day of the first patient visit
Assess real-world progression free survival (rwPFS) using data collected at 12 months.
Zeitfenster: 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.
Zeitfenster: 12 months
description of progression will be collected,
12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Juni 2026

Primärer Abschluss (Geschätzt)

30. September 2029

Studienabschluss (Geschätzt)

30. September 2029

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

29. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D0817R00131

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Zeitrahmen

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-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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