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Clinical Trial Summary

For the treatment of locally recurrent prostate cancer following failed external beam radiation therapy (EBRT)


Clinical Trial Description

The proposed study is a non-randomized, prospective, single arm study. The safety and effectiveness of the Sonablate treatment in subjects with locally recurrent prostate cancer will be evaluated with regard to freedom from biochemical failure and disease recurrence following HIFU treatment.

Men with histologically confirmed, locally recurrent, organ-confined, non-metastatic prostatic adenocarcinoma two or more years following EBRT, PSA ≥0.5 ng/mL and ≤10 ng/mL, 40 to 85 years of age, and with initial staging of T1c-T2 prior to radiation, who meet the criteria for salvage treatment, will be enrolled.

This pivotal study will cover pre-treatment through the 12-month post-treatment follow-up visit (8 visits).

A 5 year extended follow-up study will be conducted annually for the 2nd-5th years post treatment (4 additional visits). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00772317
Study type Interventional
Source SonaCare Medical
Contact
Status Active, not recruiting
Phase N/A
Start date July 2008
Completion date December 2021

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