CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Bicalutamide +5 moredrug
Likely dose
Not stated in 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/NCT00589472
NCT00589472Phase 2Completed

Neoadjuvant Androgen Depletion in Combination With Vorinostat Followed by Radical Prostatectomy for Localized Prostate Cancer: Total Androgen-Receptor Gene Expression Targeted Therapy (TARGET)

National Cancer Institute (NCI)·interventional·Posted Jan 9, 2008·Updated Oct 6, 2017

In Brief

A Phase 2 clinical trial evaluating Bicalutamide, Goserelin Acetate, and 4 other interventions for Prostate Adenocarcinoma and 4 related conditions. Completed, enrolled 19 participants across 15 sites.

Detailed Summary

This phase II trial studies how well androgen deprivation therapy and vorinostat followed by radical prostatectomy works in treating patients with prostate cancer that has not spread to other parts of the body. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin acetate, and leuprolide acetate, may lessen the amount of androgens made by the body. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving androgen deprivation therapy and vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 9, 2008
Enrollment StartNov 1, 2007
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.5 years ago

Interventions

Bicalutamidedrug

Given PO

Goserelin Acetatedrug

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Leuprolide Acetatedrug

Given IM

Therapeutic Conventional Surgeryprocedure

Undergo radical prostatectomy

Vorinostatdrug

Given PO