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

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ClinicalTrials.gov Identifier: NCT00295802
Recruitment Status : Unknown
Verified February 2014 by EDAP TMS S.A..
Recruitment status was:  Active, not recruiting
First Posted : February 24, 2006
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
EDAP TMS S.A.

Tracking Information
First Submitted Date  ICMJE February 22, 2006
First Posted Date  ICMJE February 24, 2006
Last Update Posted Date February 7, 2014
Study Start Date  ICMJE April 2006
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2006)
  • Attainment achievement of PSA nadir < 0.5 ng/ml and stability of PSA according to ASTRO criteria through 15 month follow up without a positive biopsy.
  • Study success is defined as the demonstration that the rate of patients in the Ablatherm treatment group with a nadir PSA within 6 months < 0.5 ng/ml and stability of PSA according to ASTRO criteria through 15 month follow up without a positive biopsy is
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • Achievement of a nadir PSA within 6 months < 0.5 ng/ml [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • Change from baseline in the International Prostate Symptom Score (IPSS) [ Time Frame: 1 month, 6 months, 12 months, 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2006)
  • Achievement of a nadir PSA within 6 months < 0.5 ng/ml
  • Overall survival, defined as time to death due to any cause
  • Disease specific survival, defined as the time to death due to the underlying disease
  • Change from baseline in the UCLA QOL
  • Change from baseline in the IPSS score
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2014)
The occurrence of adverse events and device-related adverse events reported [ Time Frame: through out study ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
Official Title  ICMJE Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Device: Integrated Imaging High Intensity Focused Ultrasound
    Other Name: HIFU
  • Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
    Cryotherapy
    Other Names:
    • Endocare CRYOcare Cryosurgical
    • Galil Medical CRYO-HIT Systems (cryotherapy)
Study Arms  ICMJE
  • Experimental: HIFU
    Integrated Imaging High Intensity Focused Ultrasound using the Ablatherm Device
    Intervention: Device: Integrated Imaging High Intensity Focused Ultrasound
  • Active Comparator: Cryotherapy
    Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
    Intervention: Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)
Publications * Thüroff S, Chaussy C, Vallancien G, Wieland W, Kiel HJ, Le Duc A, Desgrandchamps F, De La Rosette JJ, Gelet A. High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. J Endourol. 2003 Oct;17(8):673-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 6, 2014)
141
Original Enrollment  ICMJE
 (submitted: February 22, 2006)
460
Estimated Study Completion Date  ICMJE September 2014
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00295802
Other Study ID Numbers  ICMJE G050103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EDAP TMS S.A.
Study Sponsor  ICMJE EDAP TMS S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carey Robertson, MD Duke University
PRS Account EDAP TMS S.A.
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP