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Androgen Biosynthesis Inhibitor

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

Q: What condition is Niraparib most often given to treat?

Niraparib is most often used to treat thyroiditis, but it can also be helpful in managing <a href="https://www.withpower.com/clinical-trials/ulcerative-colitis">ulcerative colitis</a>, certain types of <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a>, and varicella-zoster virus acute retinal necrosis.

Q: Has the FDA cleared Niraparib for use?

Niraparib's safety is well-documented, as this drug has completed Phase 3 clinical trials. These multiple rounds of testing confirm both efficacy and a strong safety profile.

Q: Are recruitment efforts still underway for this research project?

Unfortunately, this study is not currently looking for patients. The trial was posted on January 25th, 2019 and updated October 25th, 2022. There are 1,755 other trials that may be of interest to you.

Q: Is there any precedent for prescribing Niraparib?

There are 466 Niraparib trials currently underway worldwide, with 111 of them being in the final stage of testing. The majority of these trials take place in Duarte, <a href="https://www.withpower.com/clinical-trials/california">California</a>; however, there are 18846 locations running studies for this treatment.

Q: How many people will be participating in this research?

Recruitment for this study has concluded. The trial was initially posted on 1/25/2019 and updated for the last time on 10/25/2022. There are 1289 other trials actively recruiting patients with castration resistant prostatic <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> and 466 studies seeking participants for Niraparib.

Q: How many clinical sites are participating in this research study?

Currently, there are 19 sites conducting this study. They are situated in places such as Salt Lake City, Bala-Cynwyd, Riverside and other 16 cities. To limit travel time and stress, please choose the location nearest you.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 97 months

Awards & highlights

MAGNITUDE 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.Check my eligibility

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.See study design

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.

MAGNITUDE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

My cancer has a positive HRR gene alteration.

Select...

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

Select...

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

Select...

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

Select...

My worst pain in the last 24 hours was mild.

MAGNITUDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 97 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 97 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 97 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Cohort 1: Overall Survival (OS)

Cohort 1: Time to Initiation of Cytotoxic Chemotherapy

Cohort 1: Time to Symptomatic Progression

+5 more

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%

Dyspnea

22%

Abdominal pain

22%

Dizziness

22%

Insomnia

17%

Headache

17%

Platelet count decreased

17%

Mucositis oral

17%

Creatinine increased

13%

Sinus tachycardia

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

Anxiety

Alanine aminotransferase increased

Urinary tract infection

Dehydration

Back pain

Blood bilirubin increased

Dry mouth

Cough

Hypertension

Non-cardiac chest pain

Esophageal ulcer

Skin tear

Diarrhea

Edema limbs

Leukocytosis

Syncope

Hypotension

Head injury

Oral petechia

Sinus pain

Unknown infection

Ascites

Bruising

Itchy eyes

Flu like symptoms

Hoarseness

Peripheral sensory neuropathy

Sore throat

Upper respiratory infection

Neutrophil count decreased

Lung infection

White blood cell decreased

Depression

Hyponatremia

Hypokalemia

Postnasal drip

Hyperkalemia

Bloating

Hot flashes

Hyperglycemia

Hematuria

Tremor

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

MAGNITUDE 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

~1540

Abiraterone Acetate

2015

Completed Phase 4

~1880

Prednisone

2014

Completed Phase 4

~2370

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,383,543 Total Patients Enrolled

8 Trials studying Prostate Cancer

2,178 Patients Enrolled for Prostate Cancer

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,140 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Clinical Trial 2023: Abiraterone Acetate Highlights & Side Effects. Trial Name: NCT03748641 — Phase 3

Abiraterone Acetate (Androgen Biosynthesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03748641 — Phase 3

Prostate Cancer Research Study Groups: Cohort 1: Participants with mCRPC and HRR Gene Alteration, Cohort 2: Participants with mCRPC and No HRR Gene Alteration, Cohort 3 (Open-label): Participants with mCRPC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What condition is Niraparib most often given to treat?

"Niraparib is most often used to treat thyroiditis, but it can also be helpful in managing ulcerative colitis, certain types of cancer, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Has the FDA cleared Niraparib for use?

"Niraparib's safety is well-documented, as this drug has completed Phase 3 clinical trials. These multiple rounds of testing confirm both efficacy and a strong safety profile."

Answered by AI

Are recruitment efforts still underway for this research project?

"Unfortunately, this study is not currently looking for patients. The trial was posted on January 25th, 2019 and updated October 25th, 2022. There are 1,755 other trials that may be of interest to you."

Answered by AI

Is there any precedent for prescribing Niraparib?

"There are 466 Niraparib trials currently underway worldwide, with 111 of them being in the final stage of testing. The majority of these trials take place in Duarte, California; however, there are 18846 locations running studies for this treatment."

Answered by AI

How many people will be participating in this research?

"Recruitment for this study has concluded. The trial was initially posted on 1/25/2019 and updated for the last time on 10/25/2022. There are 1289 other trials actively recruiting patients with castration resistant prostatic cancer and 466 studies seeking participants for Niraparib."

Answered by AI

How many clinical sites are participating in this research study?

"Currently, there are 19 sites conducting this study. They are situated in places such as Salt Lake City, Bala-Cynwyd, Riverside and other 16 cities. To limit travel time and stress, please choose the location nearest you."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

2019. "A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03748641.

All > Prostate Cancer Boston > Metastatic Prostate Cancer