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Steroidogenesis Inhibitor

Abiraterone acetate for Prostate Cancer

Phase 2
Waitlist Available
Led By Bridget Koontz, MD
Research Sponsored by Duke University
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 1 year, 2 years, 3 years, 4 years, 5 years
Awards & highlights

Study Summary

This trial found that adding abiraterone acetate to the standard treatment for prostate cancer (radiotherapy and short-term androgen deprivation) increased the frequency of undetectable PSA (a marker for the disease).

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year, 2 years, 3 years, 4 years, 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year, 2 years, 3 years, 4 years, 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
Secondary outcome measures
Metastasis or Systemic Therapy
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
PSA Nadir Value
+4 more

Side effects data

From 2021 Phase 3 trial • 32 Patients • NCT01517802
10%
Pulmonary Embolism
6%
Diarrhoea
6%
Fall
6%
Skin Laceration
3%
Urinary Retention
3%
Acute Kidney Injury
3%
Cardiac Failure Congestive
3%
Musculoskeletal Pain
3%
Oesophagitis
3%
Myocardial Infarction
3%
Nausea
3%
Vomiting
3%
Aortic Thrombosis
3%
Hypertension
3%
Dyspnoea
3%
Fatigue
3%
Weight Decreased
3%
Lower Respiratory Tract Infection
3%
Urinary Tract Infection
3%
Dehydration
3%
Cerebrovascular Accident
3%
Encephalopathy
3%
Spinal Cord Compression
3%
Syncope
3%
Cardiac Failure
3%
Upper Limb Fracture
3%
Aortic Valve Replacement
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abiraterone Acetate + Prednisone/Prednisolone

Trial Design

1Treatment groups
Experimental Treatment
Group I: Abiraterone acetateExperimental Treatment4 Interventions
Abiraterone Acetate, Radiotherapy and Short Term Androgen Deprivation. Prednisone will be prescribed concurrently with Abiraterone acetate.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Androgen deprivation
2014
Completed Phase 2
~80
Radiation Therapy
2017
Completed Phase 3
~7250
Abiraterone acetate
2014
Completed Phase 3
~3440

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,449 Total Patients Enrolled
42 Trials studying Prostate Cancer
96,757 Patients Enrolled for Prostate Cancer
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,034 Total Patients Enrolled
4 Trials studying Prostate Cancer
203 Patients Enrolled for Prostate Cancer
Bridget Koontz, MDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
69 Total Patients Enrolled
2 Trials studying Prostate Cancer
39 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer
2014. "Abiraterone, Radiotherapy and Short-Term Androgen Deprivation in Unfavorable Localized Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01717053.
~3 spots leftby Apr 2025
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