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Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy

NCT00480857 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-10-06

Study results available
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Summary

The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.

Conditions

Interventions

DRUG

Docetaxel (Taxotere)

Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Daniel A. Hamstra, M.D., Ph.D. · University of Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2013-08-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT00480857 on ClinicalTrials.gov