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PROLONG (PRostateOLaparibONcombinationGcc) Study (PROLONG)

25. června 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

75

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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.

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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)
Lék: 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.
Lék: 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)
Lék: Olaparib and Abiraterone Combination
Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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.
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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).
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 12 months
description of progression will be collected,
12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

AstraZeneca

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. června 2026

Primární dokončení (Odhadovaný)

30. září 2029

Dokončení studie (Odhadovaný)

30. září 2029

Termíny zápisu do studia

První předloženo

9. června 2026

První předloženo, které splnilo kritéria kontroly kvality

25. června 2026

První zveřejněno (Aktuální)

29. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • D0817R00131

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

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

Kritéria přístupu pro sdílení IPD

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

Typ podpůrných informací pro sdílení IPD

  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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