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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
EDAP TMS S.A.
ClinicalTrials.gov Identifier:
NCT00295802
First received: February 22, 2006
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Device: Integrated Imaging High Intensity Focused Ultrasound
Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by EDAP TMS S.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Achievement of a nadir PSA within 6 months < 0.5 ng/ml [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in the International Prostate Symptom Score (IPSS) [ Time Frame: 1 month, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • The occurrence of adverse events and device-related adverse events reported [ Time Frame: through out study ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: April 2006
Estimated Study Completion Date: September 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIFU
Integrated Imaging High Intensity Focused Ultrasound using the Ablatherm Device
Device: Integrated Imaging High Intensity Focused Ultrasound
Other Name: 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)

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295802

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

Publications:
Responsible Party: EDAP TMS S.A.
ClinicalTrials.gov Identifier: NCT00295802     History of Changes
Other Study ID Numbers: G050103
Study First Received: February 22, 2006
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EDAP TMS S.A.:
Prostate Cancer
HIFU
EDAP
Low Risk, Localized Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014