Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Device: HIFU (Sonablate® 500)Device: Brachytherapy
- Registration Number
- NCT00770822
- Lead Sponsor
- SonaCare Medical
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 466
- T1c or T2a carcinoma of the prostate confirmed by biopsy;
- life expectancy of 5(five) years or more;
- prostate biopsy with 10(ten) or more core biopsies;
- Gleason score of 6(six) or less;
- serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
- prostate volume of less than 40(Forty)cc;
- distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
- informed consent for the treatment study through 24 months post-treatment follow-up
- men who have had previous definitive treatment for prostate cancer;
- evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
- prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
- inability to tolerate a transrectal ultrasound;
- active urinary tract infection;
- functional bladder problems;
- prior significant rectal surgery;
- intra-prostatic calcifications greater than 1(One)cm in diameter;
- interest in future fertility;
- prostatic surgery/procedure (except biopsy) within 1(One) year;
- large median lobe of the prostate;
- use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto);
- current bladder cancer, urethral stricture, or bladder neck contracture;
- urinary tract and/or rectal fistula;
- rectal fibrosis/stenosis;
- anomaly of the rectal anatomy or mucus membrane;
- prostate seroma/abcess;
- prostatitis;
- compromised renal function or upper urinary tract disease secondary to urinary obstruction;
- bleeding disorders/coagulopathy based on measures of PT and PTT;
- implant in the prostate or within 1(One)cm of the prostate;
- zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Device, HIFU HIFU (Sonablate® 500) High Intensity Focused Ultrasound Device, brachytherapy Brachytherapy Brachytherapy
- Primary Outcome Measures
Name Time Method The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months. 24 Months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Brachytherapy Site: Grand Strand Urology
🇺🇸Myrtle Beach, South Carolina, United States
Brachytherapy Site: Urology Centers of Alabama
🇺🇸Birmingham, Alabama, United States
HIFU Site: Urology of San Antonio
🇺🇸San Antonio, Texas, United States
HIFU Site: Urology Associates
🇺🇸Nashville, Tennessee, United States
HIFU Site: Southeast Urology Network
🇺🇸Memphis, Tennessee, United States
Brachytherapy Site: Specialists in Urology
🇺🇸Naples, Florida, United States