NCT00772317

A Multicenter Clinical Study of the Sonablate®450 for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

A Multicenter Clinical Study of the Sonablate® 450 (Sonablate) for the TreAtment of Locally Recurrent Prostate Cancer With HIFU (STAR Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: SonaCare Medical · Industry
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DEVICE	High Intensity Focused Ultrasound	High Intensity Focused Ultrasound

Timeline

• Start date: 2008-07-01
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2008-10-15
• Last updated: 2019-04-10

Locations

16 sites across 2 countries: United States, Canada