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Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

NCT01076335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-09-19

Study results available
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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.

Conditions

Interventions

DRUG

Neoadjuvant Hormonal Therapy

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

DRUG

Docetaxel

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Lance Pagliaro, MD, BA · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01076335 on ClinicalTrials.gov