CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
Abiraterone acetate +3 moredrug
Likely dose
Abiraterone acetate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01717053
NCT01717053Phase 2Completed
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A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer

Duke University·interventional·Posted Oct 30, 2012·Updated Oct 10, 2022

In Brief

A Phase 2 clinical trial evaluating Abiraterone acetate, Androgen deprivation, and 2 other interventions for Prostate Cancer. Completed, enrolled 37 participants across 3 sites.

Detailed Summary

The addition of abiraterone acetate to standard treatment of radiotherapy and short-term androgen deprivation will increase the frequency of undetectable PSA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsJanssen Pharmaceuticals

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2012
Enrollment StartJan 17, 2014
Primary CompletionAug 24, 2017
Study CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.7 years ago

Interventions

Abiraterone acetatedrug

1000 mg orally once a day for 6 months.

Androgen deprivationdrug

LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).

Radiation Therapyradiation

Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy

Prednisonedrug

5 mg tablet once daily for 6 months.