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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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. |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olaparib and Abiraterone Combination | Drug | Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 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 |
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Inclusion Criteria:
Exclusion Criteria:
Adult male patients (age ≥18 years) with Documented diagnosis of metastatic castration-resistant prostate adenocarcinoma
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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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.
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
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
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C531550 | olaparib |
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| Describe patient demographics: age in years | Patient demographics: age collected in years | Collected at Baseline on the day of the first patient visit |
| Describe patient demographics: sex | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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). | 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. |
| Collected at Baseline on the day of the first patient visit |
| Assess real-world progression free survival (rwPFS) using data collected at 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. | description of progression will be collected, | 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |