Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions
Keywords
Prostate Cancer, Olaparib and Abiraterone
Brief summary
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).
Interventions
DRUGOlaparib and Abiraterone Combination
Observing the Effectiveness of Olaparib and Abiraterone Combination as First Line Therapy in NHA pre-exposed mCRPC patients
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe treatment patterns before the Olaparib + Abiraterone combination: Duration of previous therapies | Collected at Baseline on the day of the first patient visit | Describe the Duration of previous therapies by collecting start and end date |
| Describe treatment patterns before the Olaparib + Abiraterone combination: Previous treatment modalities (systemic treatment, surgical intervention, radiotherapy, or others). | 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). |
| Describe treatment patterns before the Olaparib + Abiraterone combination. | 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. |
| Assess real-world progression free survival (rwPFS) using data collected at 12 months. | 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. |
| Assess time to first subsequent therapy (TFST) in 1L NHA pre- exposed mCRPC patients using data collected up to 12 months. | 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. |
| Describe patient demographics: age in years | Collected at Baseline on the day of the first patient visit | Patient demographics: age collected in years |
| Describe patient demographics: sex | Collected at Baseline on the day of the first patient visit | Patient demographics: sex collected as male or female |
| Describe patient demographics: Body mass index (BMI) | Collected at Baseline on the day of the first patient visit | Patient demographics: Body mass index (BMI) collected in kg/m 2 |
| Describe patient clinical characteristics at baseline: Gleason score | Collected at Baseline on the day of the first patient visit | Patient Gleason score |
| Describe patient clinical characteristics at baseline: Eastern Cooperative Oncology Group (ECOG) performance status | Collected at Baseline on the day of the first patient visit | Patient Eastern Cooperative Oncology Group (ECOG) performance status |
| Describe patient clinical characteristics at baseline: metastasis site(s) at baseline | Collected at Baseline on the day of the first patient visit | metastasis site(s) at baseline |
| Describe patient clinical characteristics at baseline: Homologous Recombination Repair (HRR) mutation status | Collected at Baseline on the day of the first patient visit | Patient Homologous Recombination Repair (HRR) mutation status |
| Describe patient clinical characteristics at baseline: baseline serum PSA | Collected at Baseline on the day of the first patient visit | Patient baseline serum PSA |
| Describe patient clinical characteristics at baseline: Breast Cancer Gene (BRCA) mutation status | Collected at Baseline on the day of the first patient visit | Patient Breast Cancer Gene (BRCA) mutation status |
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed