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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EDAP TMS S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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