COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer (SetPace)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00770822
Recruitment Status : Active, not recruiting
First Posted : October 10, 2008
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
SonaCare Medical

Brief Summary:
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: HIFU (Sonablate® 500) Device: Brachytherapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
Study Start Date : April 2007
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Device, HIFU
High Intensity Focused Ultrasound
Device: HIFU (Sonablate® 500)
High Intensity Focused Ultrasound
Other Names:
  • SB-500
  • Sonablate 500
  • HIFU

Active Comparator: Device, brachytherapy
Device: Brachytherapy
Standard of care
Other Names:
  • Raditation Seed Implants
  • Brachy

Primary Outcome Measures :
  1. 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. [ Time Frame: 24 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00770822

Layout table for location information
United States, Alabama
Brachytherapy Site: Urology Centers of Alabama
Birmingham, Alabama, United States, 35209
United States, Florida
Brachytherapy Site: Specialists in Urology
Naples, Florida, United States, 34102
United States, South Carolina
Brachytherapy Site: Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
HIFU Site: Southeast Urology Network
Memphis, Tennessee, United States, 38119
HIFU Site: Urology Associates
Nashville, Tennessee, United States, 37209
United States, Texas
HIFU Site: Urology of San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
SonaCare Medical
Layout table for investigator information
Principal Investigator: Mark Schoenberg, M.D. Johns Hopkins Medical Institution
Layout table for additonal information
Responsible Party: SonaCare Medical Identifier: NCT00770822    
Obsolete Identifiers: NCT00485381
Other Study ID Numbers: FSI-002
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Keywords provided by SonaCare Medical:
Primary T1c/T2a organ confined prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases