Clinical Trials in Italy / NCT03748641
Active, not recruiting
Phase 3
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer
NCT03748641 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Castration-Resistant Prostatic Cancer
Investigational drug(s) / intervention(s)
Niraparib →Abiraterone Acetate →Prednisone →PlaceboNew Formulation of Niraparib and Abiraterone Acetate (AA)
Niraparib: Participants will receive niraparib 200 mg capsules or tablets once daily.
Abiraterone Acetate: Participants will receive AA 1000 mg tablets once daily.
Prednisone: Participants will receive prednisone 10 mg tablets daily.
Placebo: Participants will receive matching placebo once daily.
New Formulation of Niraparib and Abiraterone Acetate (AA): Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
Study summary
The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.
Eligibility
Inclusion Criteria:
* HRR gene alteration (as identified by the sponsor's required assays) as follows:
1. Cohort 1: positive for HRR gene alteration
2. Cohort 2: not positive for DRD (that is, HRR gene alteration)
3. Cohort 3: eligible by HRR status
* Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
* Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
* Able to continue GnRHa during the study if not surgically castrate
* Score of \<= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)
Exclusion Criteria:
* Prior treatment with a poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor
* Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone \[AAP\] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
* Symptomatic brain metastases
* History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
* Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) \<= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
Primary outcome measure(s)
- Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) — Up to 32 months
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; (2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan less than (\<) 2 new bone lesions compared to baseline, the initial scan \>=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan \>=6 weeks later. - Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) — Up to 32 months
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurred first. Radiographic progression was determined by: (1) progression of soft tissue lesions measured by CT or MRI as per RECIST 1.1; (2) Progression of bone lesions observed by bone scan based on PCWG3 criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan \>=6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan \>=2 new lesions indicate progression; scan does not show \>=2 new lesions means no progression. If Week 8 scan \<2 new bone lesions compared to baseline, the initial scan \>=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan \>=6 weeks later.
Trial sites (318)
| Facility | City | Region | Status |
|---|---|---|---|
| Urology Centers Of Alabama | Homewood | Alabama | |
| Mayo Clinic Arizona | Phoenix | Arizona | |
| Urological Associates of Southern Arizona, P.C. | Tucson | Arizona | |
| Arkansas Urology | Little Rock | Arkansas | |
| Kaiser Permanente | Riverside | California | |
| San Bernardino Urological Associates | San Bernardino | California | |
| University of California San Francisco | San Francisco | California | |
| Sansum Clinic Pharm | Santa Barbara | California | |
| The Urology Center of Colorado | Denver | Colorado | |
| Colorado Clinical Research | Lakewood | Colorado | |
| VA Connecticut Healthcare | West Haven | Connecticut | |
| Bay Pines VA Healthcare System | Bay Pines | Florida | |
| Advanced Urology Institute | Daytona Beach | Florida | |
| University of Florida Health Jacksonville | Jacksonville | Florida | |
| Mayo Clinic - Division Of Hematology/oncology | Jacksonville | Florida | |
| Veterans Affairs Medical Ctr | Hines | Illinois | |
| Fort Wayne Medical Oncology and Hematology | Fort Wayne | Indiana | |
| First Urology | Jeffersonville | Indiana | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Norton Healthcare | Louisville | Kentucky | |
| Ochsner Clinic Foundation | New Orleans | Louisiana | |
| Rcca Md, Llc | Bethesda | Maryland | |
| Chesapeake Urology Research Associates | Towson | Maryland | |
| Massachusetts General | Boston | Massachusetts | |
| Michigan Institute of Urology | Troy | Michigan | |
| Kansas City Veterans Affairs Medical Center | Kansas City | Missouri | |
| Adult Pediatric Urology & Urogynecology, P.C | Omaha | Nebraska | |
| Nebraska Cancer Specialists | Omaha | Nebraska | |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | |
| Delaware Valley Urology, LLC | Mount Laurel | New Jersey | |
| New York Oncology Hematology | Albany | New York | |
| Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Upstate Cancer Center | Syracuse | New York | |
| Helios Clinical Research, LLC | Middleburg Heights | Ohio | |
| Oregon Urology Institute | Springfield | Oregon | |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | |
| Lancaster Urology | Lancaster | Pennsylvania | |
| VA Pittsburgh | Pittsburgh | Pennsylvania | |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina |
+ 278 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03748641 on ClinicalTrials.gov ↗ ← All trials in Italy