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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Endocare, Inc. Gen-Probe, Inc. |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00877682 |
To determine the efficacy and safety of regional cryoablation of the dominant prostate tumor as definitive therapy for clinical prostate cancer.
Condition | Intervention |
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Prostate Cancer |
Procedure: Cryoablation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Regional Cryoablation for Localized Adenocarcinoma of the Prostate |
Estimated Enrollment: | 100 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Cryotherapy: Experimental |
Procedure: Cryoablation
Under general anesthetic using ultrasonic guidance, freezing (cryoablation) portion of prostate.
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Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Metastatic disease by bone scintigraphy is exclusionary.
Contact: John F. Ward, MD | 713-792-3250 |
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: John F. Ward, MD |
Principal Investigator: | John F. Ward, MD | UT MD Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( John F. Ward, MD / Assistant Professor ) |
Study ID Numbers: | 2008-0244 |
Study First Received: | April 7, 2009 |
Last Updated: | April 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00877682 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prostate Cancer Prostate Tumor Adenocarcinoma of the Prostate PCA Regional Prostate Cryoablation |
Cryotherapy Cryoablation Health Related Quality of Life HRQOL |
Prostatic Diseases Genital Neoplasms, Male Anesthetics, General Anesthetics Quality of Life |
Urogenital Neoplasms Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |