Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer

February 6, 2014 updated by: EDAP TMS S.A.
The purpose of this study is to determine the substantial equivalence of the Ablatherm high intensity focused ultrasound (HIFU) as compared to cryotherapy for the treatment of low risk, localized prostate cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary hypothesis of this clinical investigation is that HIFU with the Ablatherm Integrated Imaging is non-inferior to minimally invasive cryosurgery as an effective treatment method for low risk, localized prostate cancer.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • Maple Leaf HIFU
  • United States
    • California
      • Arcadia, California, United States, 91006
        • Chinn & Chinn Urology Associates
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Univeristy of Colorado Hospital and Health Science Center
    • Florida
      • Ocala, Florida, United States, 34474
        • Florida Foundation for Healthcare Research Inc
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Brooklyn, New York, United States, 11215
        • Brooklyn Urology Research Group
      • New York, New York, United States, 10021
        • Sloan-Kettering Institute
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2765
        • Vanderbilt University Medical Center
    • Texas
      • Arlington, Texas, United States, 76017
        • Urolgoy Associates of North Texas
      • Houston, Texas, United States, 77230
        • The University of Texas M.D. Anderson Cancer Center
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Virginia Urology Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Diagnosis of prostate cancer confirmed by PSA and prostate biopsy
  • Male subjects, aged equal to or over 50 years
  • Organ-confined prostate cancer, clinical stage T1a, b, or c or T2a
  • At least one positive biopsy within the previous 6 months
  • PSA equal to or less than 10 ng/ml
  • Gleason score equal to or less than 6
  • Histological grading of 3+3, 3+2, 2+3, 2+4, or 2+2 based upon the baseline transrectal ultrasound (TRUS)-guided 10 core biopsy results. A subject with a histological grading of primary 4 will not be permitted for study enrollment.
  • Prostate volume equal to or less than 40 cc
  • Prostate anteroposterior (AP) diameter equal to or less than 25 mm
  • Normal rectal anatomy and rectal mucosa
  • Maximum rectal wall measurement 6 mm
  • The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria
  • The subject is willing and able to read, understand, and sign the study specific informed consent form
  • The subject agrees to comply with study protocol requirements, including HIFU or cryotherapy treatment and all follow up visit requirements through 24 months of follow up treatment.

Exclusion Criteria:

  • Evidence of seminal vesicle involvement
  • Evidence of lymph node involvement or metastasis
  • Any previous treatment for prostate cancer including: external beam radiation therapy (EBRT), hormone therapy and/or previous bilateral orchiectomy
  • Previous surgery or procedure of the prostate (except prostate biopsy) or urethra within the prior one year
  • Calcification inducing a shadow in the prostate which cannot be included in the targeted volume
  • Large median lobe of the prostate which cannot be included in the target volume
  • Use within the previous 2 months of finasteride
  • Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease
  • Active inflammatory bowel syndrome
  • Current superficial bladder cancer, urethral stricture, or bladder neck contracture
  • Active urinary tract infection or prostatitis (the subject may be enrolled once the infection has been treated and has resolved)
  • Compromised renal function or upper urinary tract disease as a result of urinary obstruction
  • A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
  • Urinary tract or rectal fistula
  • Rectal fibrosis, rectal stenosis, or other anomalies making the Ablatherm Integrated Imaging rectal probe insertion difficult
  • Anatomical anomaly of the rectum or anomaly of the rectal mucous membrane
  • Prostate seroma, prostate abscess, or urethral stenosis
  • An intraprostatic implant such as a stent or catheter, or any implant or prosthesis at less than 1 cm from the prostate
  • Interest in future fertility
  • Concurrent illness, disability, or geographical residence would hamper attendance at required study visits
  • Known latex hypersensitivity
  • Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment
  • The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the HIFU or cryotherapy procedure and study-related follow up visit requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HIFU
Integrated Imaging High Intensity Focused Ultrasound using the Ablatherm Device
Device: Integrated Imaging High Intensity Focused Ultrasound
Other Names:
  • HIFU
ACTIVE_COMPARATOR: Cryotherapy
Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Cryotherapy
Other Names:
  • Endocare CRYOcare Cryosurgical
  • Galil Medical CRYO-HIT Systems (cryotherapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Attainment achievement of prostate-specific antigen (PSA) nadir < 0.5 ng/ml and stability of PSA according to American Society for Therapeutic Radiology and Oncology (ASTRO) criteria through 24 month follow up without a positive biopsy
Time Frame: Through 24 month period
Through 24 month period

Secondary Outcome Measures

Outcome Measure
Time Frame
Achievement of a nadir PSA within 6 months < 0.5 ng/ml
Time Frame: 6 months
6 months
Overall survival, defined as time to death due to any cause
Time Frame: From date of treatment until the date of death due to any cause
From date of treatment until the date of death due to any cause
Disease specific survival, defined as the time to death due to the underlying disease
Time Frame: "From date of treatment until the date of death due to the underlying cause
"From date of treatment until the date of death due to the underlying cause
Change from baseline in the University of California, Los Angeles Quality of Life (UCLA QOL)
Time Frame: 1 month, 6 months, 12 months, 24 months
1 month, 6 months, 12 months, 24 months
Change from baseline in the International Prostate Symptom Score (IPSS)
Time Frame: 1 month, 6 months, 12 months, 24 months
1 month, 6 months, 12 months, 24 months

Other Outcome Measures

Outcome Measure
Time Frame
The occurrence of adverse events and device-related adverse events reported
Time Frame: through out study
through out study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EDAP TMS S.A.

Investigators

  • Principal Investigator: Carey Robertson, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ANTICIPATED)

September 1, 2014

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (ESTIMATE)

February 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G050103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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