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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: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Prostate Cancer
 Device: HIFU (Sonablate® 500)
Device: Brachytherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USHIFU, LLC:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 466
Study Start Date: April 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Brachytherapy
 Device: Brachytherapy
Standard of care
Other Names:
  • Raditation Seed Implants
  • Brachy

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770822

Locations
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
USHIFU, LLC
Investigators
Principal Investigator: Mark Schoenberg, M.D. Johns Hopkins Medical Institution
  More Information

No publications provided

Responsible Party: USHIFU, LLC
ClinicalTrials.gov Identifier: NCT00770822     History of Changes
Obsolete Identifiers: NCT00485381
Other Study ID Numbers: FSI-002
Study First Received: October 9, 2008
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by USHIFU, LLC:
Primary
Prostate
Cancer
Primary T1c/T2a organ confined prostate cancer
organ-confined

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013