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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIFU (Sonablate® 500)
Brachytherapy
Sponsored by
SonaCare Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Primary, Prostate, Cancer, Primary T1c/T2a organ confined prostate cancer, organ-confined

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Brachytherapy Site: Urology Centers of Alabama
  • Brachytherapy Site: Specialists in Urology
  • Brachytherapy Site: Grand Strand Urology
  • HIFU Site: Southeast Urology Network
  • HIFU Site: Urology Associates
  • HIFU Site: Urology of San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device, HIFU

Device, brachytherapy

Arm Description

High Intensity Focused Ultrasound

Brachytherapy

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
October 9, 2008
Last Updated
April 9, 2019
Sponsor
SonaCare Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00770822
Brief Title
Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer
Acronym
SetPace
Official Title
A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2007 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SonaCare Medical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Primary, Prostate, Cancer, Primary T1c/T2a organ confined prostate cancer, organ-confined

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device, HIFU
Arm Type
Experimental
Arm Description
High Intensity Focused Ultrasound
Arm Title
Device, brachytherapy
Arm Type
Active Comparator
Arm Description
Brachytherapy
Intervention Type
Device
Intervention Name(s)
HIFU (Sonablate® 500)
Other Intervention Name(s)
SB-500, Sonablate 500, HIFU
Intervention Description
High Intensity Focused Ultrasound
Intervention Type
Device
Intervention Name(s)
Brachytherapy
Other Intervention Name(s)
Raditation Seed Implants, Brachy
Intervention Description
Standard of care
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Schoenberg, M.D.
Organizational Affiliation
Johns Hopkins Medical Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brachytherapy Site: Urology Centers of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Brachytherapy Site: Specialists in Urology
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Brachytherapy Site: Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
HIFU Site: Southeast Urology Network
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
HIFU Site: Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
HIFU Site: Urology of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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