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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: HIFU (Sonablate® 500); Device: Brachytherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 466
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Brachytherapy Site: Urology Centers of Alabama
  • Florida
    • Naples, Florida, United States, 34102
      • Brachytherapy Site: Specialists in Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Brachytherapy Site: Grand Strand Urology
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • HIFU Site: Southeast Urology Network
    • Nashville, Tennessee, United States, 37209
      • HIFU Site: Urology Associates
  • Texas
    • San Antonio, Texas, United States, 78229
      • HIFU Site: Urology of San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device, HIFU; High Intensity Focused Ultrasound	Device: HIFU (Sonablate® 500); High Intensity Focused Ultrasound; Other Names: Sonablate 500; HIFU; SB-500
Active Comparator: Device, brachytherapy; Brachytherapy	Device: Brachytherapy; Standard of care; Other Names: Raditation Seed Implants; Brachy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: SonaCare Medical
• Investigators: Principal Investigator: Mark Schoenberg, M.D., Johns Hopkins Medical Institution

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 10, 2008

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Prostate; Primary; Primary T1c/T2a organ confined prostate cancer; organ-confined
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: FSI-002