CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Neoadjuvant Hormonal Therapy +1 moredrug
Likely dose
Docetaxel 35 mg/m2from 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/NCT01076335
NCT01076335Phase 2Completed
CompareCT.gov

Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer

M.D. Anderson Cancer Center·interventional·Posted Feb 26, 2010·Updated Sep 19, 2016

In Brief

A Phase 2 clinical trial evaluating Neoadjuvant Hormonal Therapy and Docetaxel for Prostate Cancer. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2010
Enrollment StartMay 1, 2005
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 16.3 years ago

Interventions

Neoadjuvant Hormonal Therapydrug

Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year.

Docetaxeldrug

35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks.