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Chemotherapy, Hormone Therapy, and Surgery to Remove the Prostate Gland in Patients With High Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00108290
Recruitment Status : Completed
First Posted : April 15, 2005
Last Update Posted : April 4, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
In men with prostate cancer who do not have evidence of spread to bone or other sites on computed axial tomography (CAT) scan/bone scan but are still at significant risk of failing treatment with surgery or radiation alone, a combination of chemotherapy and hormone therapy is being given for 6 months followed by surgery to remove the prostate.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Chemotherapy Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemohormone Therapy Prior to Prostatectomy in High Risk Prostate Cancer
Study Start Date : April 2004
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk prostate cancer without evidence of bone metastasis.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108290


Locations
United States, Maryland
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
More Information

ClinicalTrials.gov Identifier: NCT00108290     History of Changes
Other Study ID Numbers: CLIN-003-02F
First Posted: April 15, 2005    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: April 2007

Keywords provided by VA Office of Research and Development:
Prostate cancer
chemotherapy
hormone therapy
surgery
PSA
Gleason score

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases