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PARP Inhibitor

Niraparib for Prostate Cancer (Galahad Trial)

Phase 2

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 52 months

Awards & highlights

Galahad Trial Summary

This trial will test the effects of a new drug, niraparib, on men with metastatic prostate cancer that has continued to grow despite hormone therapy.

Galahad Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 52 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 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

Malignant Neoplasms

Secondary outcome measures

Circulating Tumor Cells (CTC) Response Rate

Duration of Objective Response

Number of Participants With Adverse Events (AEs)

+7 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

Galahad Trial Design

1Treatment groups

Experimental Treatment

Group I: NiraparibExperimental Treatment1 Intervention

Participants will receive 300 milligram (mg) niraparib (3 capsules*100 mg) orally once daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~1540

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,019 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

3,959,616 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,688 Patients Enrolled for Prostate Cancer

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02854436 — Phase 2

Prostate Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT02854436 — Phase 2

Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02854436 — Phase 2

Prostate Cancer Research Study Groups: Niraparib

Frequently Asked Questions

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

Are there still vacancies for this clinical trial?

"As of this moment, there is no longer a need for participants in the trial. It was initially published on August 31st 2016 and last amended on November 22nd 2022. Should you still be searching for other opportunities, 1359 studies are actively enrolling those with prostate cancer while 99 trials involve Niraparib as the medication."

Answered by AI

Has Niraparib been certified by the FDA?

"Based on our team's evaluation, Niraparib scored a 2 out of 3 for safety as it is currently in Phase 2 clinical trials and there has been some data collected regarding its safety but no evidence to support efficacy."

Answered by AI

How many volunteers are taking part in this clinical experiment?

"Unfortunately, this clinical trial is currently not enrolling patients. It was initially published on August 31st 2016 and last updated November 22nd 2022. However, there are 1359 prostate cancer trials seeking participants and 99 Niraparib studies actively recruiting people for their research."

Answered by AI

Are there numerous locations conducting this research in Canada?

"Currently, 28 different medical centres are recruiting participants for this trial. Montreal, Fairfax and Charlottesville have sites as well many other cities. It is beneficial to select a nearby location to reduce the amount of travelling needed if you choose to be part of it."

Answered by AI

Does this clinical trial introduce a new approach to treatment?

"At present, there are 99 ongoing clinical trials for Niraparib in cities spanning 49 countries. In 2016, Myriad Genetics Inc. launched the first major trial which had 733 participants and achieved Phase 3 drug approval status. Since then 17 other studies have reached completion."

Answered by AI

Has Niraparib been tested in any prior clinical investigations?

"Currently, 99 clinical studies related to Niraparib are being conducted with 13 reaching Phase 3. The primary research centre is located in Washington D.C., but 2816 diverse sites around the world have joined the trial cohort for this drug."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Niraparib in Patients with Metastatic Castration-resistant Prostate Cancer and DNA Repair Gene Defects (GALAHAD): A Multicentre, Open-label, Phase 2 Trial

Smith, Matthew R, Howard I Scher, Shahneen Sandhu, Eleni Efstathiou, Primo N Lara Jr, Evan Y Yu, Daniel J George, et al.. 2022. “Niraparib in Patients with Metastatic Castration-resistant Prostate Cancer and DNA Repair Gene Defects (GALAHAD): A Multicentre, Open-label, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00757-9.

clinicaltrials.govStudy

An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

2016. "An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02854436.