CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Docetaxel +3 moredrug
Likely dose
Docetaxel 30 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/NCT00500110
NCT00500110Phase 2Completed
CompareCT.gov

Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer

M.D. Anderson Cancer Center·interventional·Posted Jul 12, 2007·Updated Apr 28, 2015

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Imatinib Mesylate, and 2 other interventions for Prostate Cancer. Completed, enrolled 39 participants across 1 site.

Detailed Summary

Primary Objective: 1\. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation, Imatinib and Docetaxel (HID) in high-risk localized prostate cancer. Secondary Objectives: 1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant HID and radical prostatectomy in high-risk localized prostate cancer. 2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor Receptor (PDGFR) pathway.

Study Details

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

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2007
Enrollment StartJun 1, 2003
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 19.0 years ago

Interventions

Docetaxeldrug

30 mg/m\^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.

Imatinib Mesylatedrug

600 mg by mouth (PO) Daily x 42 Days.

Leuprolidedrug

Hormone injections given every other month or every 3 months, as determined by the doctor.

Goserelin Acetatedrug

Hormone injections given every other month or every 3 months, as determined by the doctor.