# MAGNITUDE

Source: https://onco.cc/trials/magnitude/  
OnCo record `magnitude` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

PARP inhibitor plus abiraterone helped men with BRCA mutations and did nothing for those without, settling a debate.

## Summary

MAGNITUDE, trial NCT03748641 sponsored by Janssen and reported in 2022, tested adding the PARP inhibitor niraparib to abiraterone in first-line metastatic castration-resistant prostate cancer in separate cohorts with and without homologous recombination repair alterations, and it settled a debate: the combination helped men with BRCA mutations and did nothing for those without. The HRR-negative cohort was stopped for futility, while the BRCA cohort met its radiographic progression-free survival endpoint and showed a survival benefit at update, and the fixed-dose combination Akeega was approved in 2023 for BRCA-mutant disease. OnCo links it to BRCA1 and BRCA2 as targets, to niraparib and abiraterone acetate. Whether the negative HRR-negative result applies to other PARP inhibitors is the open question.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-06
- Registry id: NCT03748641
- Phase: 3
- Setting: First-line mCRPC: abiraterone + niraparib vs abiraterone + placebo, HRR-mutant and HRR-negative cohorts
- Sponsor: Janssen
- Enrolled: 423
- Result: BRCA cohort rPFS HR 0.53; HRR-negative futility.
- Outcomes: Radiographic progression-free survival, BRCA1/2 subgroup: Niraparib + abiraterone 16.6 months vs Placebo + abiraterone 10.9 months, HR 0.53
- Replication: Consistent with PROpel and TALAPRO-2 in BRCA-mutant disease; the HRR-negative cohort showed no benefit and was stopped for futility.

## Notes

- Niraparib with abiraterone acetate and prednisone has no NICE recommendation in England. NICE TA1032, terminated on 22 January 2025, states that NICE is unable to make a recommendation because Johnson and Johnson Innovative Medicine did not provide an evidence submission, and that the decision will be reviewed if the company submits. A terminated appraisal is not a refusal on the evidence; it is the absence of any evidence for NICE to appraise.

## Sources

- ClinicalTrials.gov NCT03748641: https://clinicaltrials.gov/study/NCT03748641
- NICE TA1032: niraparib with abiraterone acetate and prednisone for untreated hormone-relapsed metastatic prostate cancer, terminated appraisal: https://www.nice.org.uk/guidance/terminated/ta1032

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/)
- drugs: [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Niraparib](https://onco.cc/drugs/niraparib/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [Data monitoring committee (DSMB, IDMC)](https://onco.cc/terms/data-monitoring-committee/), [Enrichment and biomarker-stratified designs](https://onco.cc/terms/biomarker-stratified-design/), [Futility analysis (stopped for futility)](https://onco.cc/terms/futility/), [Group sequential design, stopping rules and alpha spending](https://onco.cc/terms/group-sequential-design/), [Pre-specified vs post-hoc analysis](https://onco.cc/terms/prespecified-vs-post-hoc/), [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/), [Subgroup analysis (forest plots)](https://onco.cc/terms/subgroup-analysis/), [Who is eligible for a PARP inhibitor in prostate cancer, and why the gene matters](https://onco.cc/terms/prostate-hrr-eligibility/)
- trials: [PROpel](https://onco.cc/trials/propel/), [TALAPRO-2](https://onco.cc/trials/talapro-2/), [TRITON3](https://onco.cc/trials/triton3/)
- people: [Kim N. Chi](https://onco.cc/people/kim-chi/)
- key papers: [Niraparib and Abiraterone Acetate for Metastatic Castration-Resistant Prostate Cancer](https://onco.cc/key-papers/paper-magnitude-j-clin-oncol-2023/)
- roadmaps: [Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test](https://onco.cc/roadmaps/hormonal-therapy-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/magnitude.json