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Androgen Biosynthesis Inhibitor

Niraparib + Abiraterone Acetate + Prednisone for Metastatic Prostate Cancer (MAGNITUDE Trial)

Phase 3

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Cohort 1: positive for HRR gene alteration

Must not have

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

History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 32 months

Awards & highlights

Pivotal Trial

Summary

This trial will compare the effect of adding niraparib to abiraterone acetate plus prednisone, versus abiraterone acetate plus prednisone and placebo, in men with metastatic castration-resistant prostate cancer.

Who is the study for?

This trial is for men with metastatic prostate cancer who have specific genetic changes (HRR gene alteration), haven't had certain cancers or treatments like PARP inhibitors, and are on hormone therapy to keep testosterone low. They should not have symptomatic brain tumors or blood disorders like MDS/AML.

What is being tested?

The study tests the effectiveness of Niraparib combined with Abiraterone Acetate and Prednisone against just Abiraterone Acetate and Prednisone in treating metastatic prostate cancer. Participants will be randomly assigned to either receive the combination treatment or the standard treatment plus a placebo.

What are the potential side effects?

Possible side effects include fatigue, nausea, anemia (low red blood cell count), potential heart issues, shortness of breath, and other symptoms that can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has spread, and my testosterone is very low due to treatment or surgery.

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My cancer has a positive HRR gene alteration.

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My cancer has spread, confirmed by a bone scan or CT/MRI.

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My cancer has a specific gene change identified by a special test.

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My cancer does not have a specific gene alteration (DRD negative).

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My worst pain in the last 24 hours was mild.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had specific prostate cancer treatments before joining this study.

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I have or had myelodysplastic syndrome or acute myeloid leukemia.

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I have brain metastases that are causing symptoms.

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I have been treated with a PARP inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 32 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 32 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 32 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort 1 Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Abdominal pain

22%

Dizziness

22%

Insomnia

22%

Dyspnea

17%

Platelet count decreased

17%

Headache

17%

Mucositis oral

17%

Creatinine increased

13%

Rash maculo-papular

13%

Vomiting

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Dehydration

Cough

Urinary tract infection

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Upper respiratory infection

Hoarseness

Hypotension

Postnasal drip

Head injury

Hyponatremia

Flu like symptoms

Hyperglycemia

Neutrophil count decreased

Tremor

Hot flashes

Hypokalemia

Diarrhea

Depression

Itchy eyes

Edema limbs

Bruising

Esophageal ulcer

Hyperkalemia

Peripheral sensory neuropathy

Leukocytosis

White blood cell decreased

Skin tear

Oral petechia

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (Open-label): Participants with mCRPCExperimental Treatment2 Interventions

Participants with mCRPC will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets plus prednisone 10 mg.

Group II: Cohort 2: Participants with mCRPC and No HRR Gene AlterationExperimental Treatment4 Interventions

Participants with L1 mCRPC and no HRR Gene alteration will receive combination of niraparib 200 mg or matching placebo and AA 1000 mg plus prednisone 10 mg. In the OLE phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.

Group III: Cohort 1: Participants with mCRPC and HRR Gene AlterationExperimental Treatment4 Interventions

Participants with L1 metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alteration will receive combination of niraparib 200 milligrams (mg) or matching placebo and abiraterone acetate (AA) 1000 mg plus prednisone 10 mg. In the open label extension (OLE) phase participants earlier receiving the combination of niraparib and AAP may continue to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg and those receiving placebo and AAP may cross over depending on the outcome of study to receive open-label combination of niraparib 200 mg and AA 1000 mg plus prednisone 10 mg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

Abiraterone Acetate

2015

Completed Phase 4

~1880