PROLONG (PRostateOLaparibONcombinationGcc) Study (PROLONG)
25 giugno 2026 aggiornato da: 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).
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Stimato)
75
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: AstraZeneca Clinical Study Information Center
- Numero di telefono: 1-877-240-9479
- Email: information.center@astrazeneca.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione di probabilità
Popolazione di studio
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.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 12 months
|
description of progression will be collected,
|
12 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
30 giugno 2026
Completamento primario (Stimato)
30 settembre 2029
Completamento dello studio (Stimato)
30 settembre 2029
Date di iscrizione allo studio
Primo inviato
9 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
25 giugno 2026
Primo Inserito (Effettivo)
29 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- D0817R00131
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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
Criteri di accesso alla condivisione 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
Tipo di informazioni di supporto alla condivisione IPD
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .