Trials / Unknown
UnknownNCT00770822
Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 466 (estimated)
- Sponsor
- SonaCare Medical · Industry
- Sex
- Male
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.
Detailed description
The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HIFU (Sonablate® 500) | High Intensity Focused Ultrasound |
| DEVICE | Brachytherapy | Standard of care |
Timeline
- Start date
- 2007-04-01
- Primary completion
- 2020-07-01
- Completion
- 2020-12-01
- First posted
- 2008-10-10
- Last updated
- 2019-04-10
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00770822. Inclusion in this directory is not an endorsement.