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Status unknownNCT00770822SetPaceUpdated Apr 10, 2019

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

An interventional study of HIFU (Sonablate® 500) and Brachytherapy in Prostate Cancer, sponsored by SonaCare Medical. Status unknown at 6 sites in United States. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by SonaCare Medical · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
466
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • Primary
  • Prostate
  • Cancer
  • Primary T1c/T2a organ confined prostate cancer
  • organ-confined
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 466 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

SonaCare Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
466 participants (estimated)

Study arms

  • Experimental
    Device, HIFU

    High Intensity Focused Ultrasound

    Device: HIFU (Sonablate® 500)

  • Active comparator
    Device, brachytherapy

    Brachytherapy

    Device: Brachytherapy

Interventions

  • DeviceHIFU (Sonablate® 500)

    High Intensity Focused Ultrasound

    Also known as: SB-500, Sonablate 500, HIFU

  • DeviceBrachytherapy

    Standard of care

    Also known as: Raditation Seed Implants, Brachy

06

What researchers measure

Primary outcomes

  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

07

Study locations

6 sites
  • Brachytherapy Site: Urology Centers of Alabama
    Birmingham, Alabama 35209, United States
  • Brachytherapy Site: Specialists in Urology
    Naples, Florida 34102, United States
  • Brachytherapy Site: Grand Strand Urology
    Myrtle Beach, South Carolina 29572, United States
  • HIFU Site: Southeast Urology Network
    Memphis, Tennessee 38119, United States
  • HIFU Site: Urology Associates
    Nashville, Tennessee 37209, United States
  • HIFU Site: Urology of San Antonio
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00770822
Lead sponsor
SonaCare Medical
Responsible party
Sponsor
First posted
Oct 10, 2008
Start date
Apr 2007
Primary completion
Jul 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Apr 10, 2019

Study contacts

Mark Schoenberg, M.D.
principal investigator · Johns Hopkins Medical Institution

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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