View Clinical Trial (Medical Research Study)
A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU - NCT00770822-(Clinical Trial 246798)
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Madison |
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State:
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WI |
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| Conditions: |
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Prostate Cancer |
| Purpose: |
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This study will compare high intensity focused ultrasound to standard brachytherapy in the
treatment of primary, organ confined prostate cancer.
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| Study summary: |
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The proposed study is a prospective, non-randomized concurrently controlled study. The
active treatment arm uses the HIFU procedure with the SB-500 device. The control arm uses
the brachytherapy procedure. The safety and effectiveness of the SB-500 arm will be
compared with the brachytherapy arm. The control arm of the study will be conducted at
clinical sites different from the SB-500 arm. |
| Criteria: |
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Inclusion Criteria:
- T1c or T2a carcinoma of the prostate;
- Gleason score ≤6;
- serum prostate specific antigen(PSA) ≤10 ng/ml;
- prostate volume <40 cc;
Exclusion Criteria:
- men who have had previous definitive treatment for prostate cancer
- prior hormonal therapy for prostate cancer (including bilateral orchiectomy) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 16, 2010 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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