PROLONG (PRostateOLaparibONcombinationGcc) Study (PROLONG)
25. juni 2026 opdateret af: 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).
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
75
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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)
|
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.
|
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)
|
Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: Collected at Baseline on the day of the first patient visit
|
|
Collected at Baseline on the day of the first patient visit
|
|
Assess real-world progression free survival (rwPFS) using data collected at 12 months.
Tidsramme: 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.
Tidsramme: 12 months
|
description of progression will be collected,
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
30. juni 2026
Primær færdiggørelse (Anslået)
30. september 2029
Studieafslutning (Anslået)
30. september 2029
Datoer for studieregistrering
Først indsendt
9. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D0817R00131
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
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-deling Understøttende informationstype
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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