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Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

NCT00500110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2015-04-28

Study results available
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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.

Conditions

Interventions

DRUG

Docetaxel

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.

DRUG

Imatinib Mesylate

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

DRUG

Leuprolide

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

DRUG

Goserelin Acetate

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

Sponsors & Collaborators

Principal Investigators

  • Paul Mathew, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500110 on ClinicalTrials.gov