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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
No Placebo-Only Group

Summary

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

Eligible Conditions
  • Prostate Cancer

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients with a non-castrate (>50 ng/dl) serum testosterone
Secondary study objectives
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
8%
anxiety
8%
xerosis
4%
elevated ALT
4%
hematochezia
4%
cough
4%
elevated AST
4%
xerostomia
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2500
Abiraterone Acetate
2015
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
456 Previous Clinical Trials
588,438 Total Patients Enrolled
3 Trials studying Prostate Cancer
292 Patients Enrolled for Prostate Cancer
Benjamin Gartrell, MDPrincipal InvestigatorMontefiore Medical Center
~4 spots leftby Nov 2025
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