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Published on: March 6, 2018
Niraparib With Abiraterone Acetate Plus Prednisone as First-Line Therapy in Patients With Metastatic
Dingwei Ye1, Marniza Saad2, Ji Youl Lee3
1Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.
Objectives:
Patients with homologous recombination repair gene altered (HRR+) metastatic castration-resistant prostate cancer (mCRPC) have a poor prognosis but achieved clinical benefits when treated with first-line niraparib and abiraterone acetate plus prednisone (niraparib + AAP) in the MAGNITUDE trial. We report final exploratory results from MAGNITUDE for the subgroup of patients with Breast Cancer gene-positive (BRCA+) mCRPC enrolled in Asia (NCT03748641).
Methods:
Participants with HRR + mCRPC were randomized 1:1 to treatment with niraparib + AAP or placebo + AAP. The primary endpoint of radiographic progression-free survival (rPFS) by blinded independent central review (BICR) and secondary survival endpoints were calculated for the BRCA+ Asian subgroup. Safety was assessed in the Asian HRR+ population.
Results:
The Asian subgroup included 35 participants with BRCA + mCRPC (all BRCA2+). After 34.99 months of follow-up, median rPFS by BICR was 38.6 months in the niraparib + AAP group versus 8.3 months in the placebo+AAP group (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.13-0.83, nominal p-value = 0.0141). Clinically relevant benefits were also observed in time to PSA progression (HR 0.32, 95% CI 0.13-0.83), and time to cytotoxic chemotherapy (HR 0.098, 95% CI 0.01-0.68). Median overall survival was not reached in the niraparib+AAP group and was 24.0 months in the placebo+AAP group (HR 0.67, 95% CI 0.27-1.71). The safety profile of niraparib+AAP was consistent with the main study population.
Conclusions:
In this final exploratory analysis of the Asian subgroup, participants with BRCA + mCRPC continued to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP, with efficacy and toxicity profiles consistent with the global study population.
Trial Registration:
United States National Library of Medicine (https://clinicaltrials.gov); NCT03748641.
Insights
First-line niraparib plus abiraterone acetate demonstrated significant radiographic progression-free survival benefits for Asian patients with BRCA-positive metastatic castration-resistant prostate cancer. Treatment showed improved outcomes compared to placebo, with a consistent safety profile.
Area of Science:
- Oncology
- Genetics
- Pharmacology
Background:
- Metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair (HRR) gene alterations has a poor prognosis.
- The MAGNITUDE trial investigated first-line niraparib plus abiraterone acetate and prednisone (AAP) in HRR-altered mCRPC.
- This analysis focuses on the BRCA-positive (BRCA+) Asian subgroup within the MAGNITUDE trial.
Purpose of the Study:
- To report final exploratory efficacy and safety results for BRCA+ mCRPC patients in Asia.
- To evaluate the benefit of first-line niraparib + AAP versus placebo + AAP in this specific subgroup.
- To compare radiographic progression-free survival (rPFS) and other endpoints.
Main Methods:
- Randomized, double-blind, placebo-controlled trial design (NCT03748641).
- Participants with HRR-altered mCRPC were randomized 1:1 to niraparib + AAP or placebo + AAP.
- Primary endpoint: rPFS by blinded independent central review (BICR); secondary endpoints included survival and time to progression. Safety assessed in Asian HRR+ population.
Main Results:
- 35 BRCA+ Asian mCRPC patients (all BRCA2+) were included.
- Median rPFS was 38.6 months with niraparib + AAP vs. 8.3 months with placebo + AAP (HR 0.33, p=0.0141).
- Significant benefits observed in time to PSA progression and time to chemotherapy; overall survival favored niraparib + AAP.
Conclusions:
- First-line niraparib + AAP provides significant clinical benefit for Asian patients with BRCA+ mCRPC.
- Efficacy and safety profiles are consistent with the global study population.
- These findings support niraparib + AAP as a valuable treatment option for this patient group.
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