CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Androgen Deprivation Therapy +2 moredrug
Likely dose
Androgen Deprivation Therapy 22.5mgfrom 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/NCT00776594
NCT00776594Phase 2Completed
CompareCT.gov

Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Dana-Farber Cancer Institute·interventional·Posted Oct 21, 2008·Updated Oct 21, 2016

In Brief

A Phase 2 clinical trial evaluating Androgen Deprivation Therapy, bicalutamide, and 1 other intervention for Prostate Cancer. Completed, enrolled 102 participants across 8 sites.

Detailed Summary

The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsGenentech, Inc., Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Rutgers Cancer Institute of New Jersey

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2008
Enrollment StartOct 1, 2008
Primary CompletionDec 1, 2014
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 17.7 years ago

Interventions

Androgen Deprivation Therapydrug

leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamidedrug

50mg orally daily for 6 months

bevacizumabdrug

15mg/ks given IV every three weeks for a total of 8 infusions over 6 months