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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
USHIFU, LLC
ClinicalTrials.gov Identifier:
NCT00770822
First received: October 9, 2008
Last updated: December 9, 2013
Last verified: December 2013

October 9, 2008
December 9, 2013
April 2007
July 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00770822 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Device: HIFU (Sonablate® 500)
    High Intensity Focused Ultrasound
    Other Names:
    • SB-500
    • Sonablate 500
    • HIFU
  • Device: Brachytherapy
    Standard of care
    Other Names:
    • Raditation Seed Implants
    • Brachy
  • Experimental: Device, HIFU
    High Intensity Focused Ultrasound
    Intervention: Device: HIFU (Sonablate® 500)
  • Active Comparator: Device, brachytherapy
    Brachytherapy
    Intervention: Device: Brachytherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
466
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Male
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00770822
FSI-002
Yes
USHIFU, LLC
USHIFU, LLC
Not Provided
Principal Investigator: Mark Schoenberg, M.D. Johns Hopkins Medical Institution
USHIFU, LLC
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP