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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00774436 |
Purpose
The purpose of this study is to find out if men, with low-risk prostate, can have the small amount of cancer within their prostate removed by freezing, called Focal Cryoablation or Cryotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: focal cryotherapy and quality-of-life questionnaires |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | A Phase II Study of Focal Cryoablation in Low-Risk Prostate Cancer |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Patients scheduled to receive Focal Cryotherapy: Experimental
After enrollment, pt's will undergo a mapping prostate bx as currently performed at our institution. Those men meeting the mapping-biopsy criteria will subsequently be treated with focal cryotherapy. Patients will be evaluated through the standard quality-of-life questionnaires, that are completed by all patients treated by the Urology Service (whether on not they are treated on an IRB protocol).
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Procedure: focal cryotherapy and quality-of-life questionnaires
Eligible patients will be scheduled to receive Focal Cryotherapy on the prostate. The procedure will be schedule to be done within 12 weeks of the initial transperineal prostate biopsy. The patient will return to clinic approximately 1 week, after treatment, for catheter removal. Also the patient will have follow-up visits about 6 weeks, 3 months, and 6 months, after focal cryotherapy, at which time a physical exam with digital rectal examination, PSA test, and Quality of Life questionnaires (except for week 6) will be performed. A repeat transperineal mapping biopsy will be done at 6 months after Focal Cryotherapy.
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Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pre-enrollment biopsy parameters (as per MSKCC review):
Exclusion Criteria:
Contacts and Locations| Contact: James Eastham, MD | easthamj@mskcc.org | |
| Contact: Jonathan Coleman, MD | colemaj1@mskcc.org |
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: James Eastham, MD easthamj@mskcc.org | |
| Contact: Jonathan Coleman, MD colemaj1@mskcc.org | |
| Principal Investigator: James Eastham, MD | |
| Principal Investigator: | James Eastham, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( James Eastham, MD ) |
| Study ID Numbers: | 08-118 |
| Study First Received: | October 15, 2008 |
| Last Updated: | July 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00774436 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
focal cryotherapy low-risk prostate cancer |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |