← Back to Search

Hormone Therapy

Abiraterone Acetate for Prostate Cancer

Phase 2

Waitlist Available

Led By Benjamin Gartrell, MD

Research Sponsored by Montefiore Medical Center

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 24 weeks

Awards & highlights

Study Summary

This trial is testing whether abiraterone and prednisone can keep testosterone levels low without the use of hormone injections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone

Secondary outcome measures

Luteinizing hormone (LH) level after discontinuation of GnRH analogue

Median overall survival

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

+2 more

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807

81%

fatigue

38%

hot flashes

38%

neuropathy

19%

alopecia;

19%

dysgeusia

15%

hiccups

15%

nausea

15%

skin alterations

12%

diarrhea

12%

gastritis

12%

edema (lower extremity)

12%

rash

12%

constipation

anxiety

xerosis

hematochezia

elevated ALT

xerostomia

cough

elevated AST

general body aches

pruritis

nail discoloration

fever

anemia

epistaxis

infusion related reaction

neutropenia

neutropenic fever

gastrointestinal reflux

pain (bilateral legs)

mucositis

pain (joint);

anorexia

nail ridging

weight gain

hematuria

urinary tract obstruction

oral candidiasis

insomnia

depression

dyspnea

arthritis

pain (pelvis)

memory impairment

heartburn

100%

80%

60%

40%

20%

Study treatment Arm

Chemohormonal and Definitive Therapy After Prostatectomy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Abiraterone and Prednisone without a GnRH AnalogueExperimental Treatment2 Interventions

Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prednisone

2014

Completed Phase 4

~2370

Abiraterone Acetate

2015

Completed Phase 4

~1880

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

441 Previous Clinical Trials

582,164 Total Patients Enrolled

3 Trials studying Prostate Cancer

292 Patients Enrolled for Prostate Cancer

Benjamin Gartrell, MDPrincipal InvestigatorMontefiore Medical Center

Frequently Asked Questions

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

Are research subjects still being sought for this experiment?

"This study, as indicated by clinicaltrials.gov, is not presently looking for patients to participate. The trial was originally posted on 6/13/2018 but was most recently edited on 9/22/2022. Although this study has concluded recruitment, there are many other medical trials that are actively recruiting patients right now."

Answered by AI

How many test subjects are in this clinical trial?

"This particular clinical trial is no longer admitting patients. The study was first posted on June 13th, 2018 and saw its last update September 22nd of this year. There are 1292 other trials for prostate cancer and 378 studies involving Abiraterone acetate that are still open to participants."

Answered by AI

How often has Abiraterone Acetate been used in other medical research projects?

"There are 378 studies currently underway that involve Abiraterone acetate, with 101 of them being Phase 3 clinical trials. Although a majority of the research is based in Duarte, California, there are 17174 locations worldwide where these trials are taking place."

Answered by AI

Do Abiraterone Acetate users experience many side effects?

"Abiraterone acetate is at a Phase 2 level, so there is some data suggesting it is safe but none yet indicating that it works. Consequently, we gave it a score of 2."

Answered by AI

For what purpose is Abiraterone Acetate most often prescribed?

"Abiraterone acetate is a medication that can be used to help with thyroiditis. However, it has also been shown to be effective in managing ulcerative colitis, malignant neoplasms, and varicella-zoster virus acute retinal necrosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer

Benjamin Gartrell 2018. "Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03565835.

All > Acth > Metastatic Prostate Cancer