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

NCT00295802 | Unknown Phase 2

• 1 other identifier: G050103
• Study Type: interventional
• Target: 141
• Locations: 2 countries
• Sites: 15

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; HIFU; EDAP; Low Risk, Localized Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Through 24 month period

Secondary Outcomes (5)

• Achievement of a nadir PSA within 6 months < 0.5 ng/ml

  6 months

• Overall survival, defined as time to 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

  "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)

  1 month, 6 months, 12 months, 24 months

• Change from baseline in the International Prostate Symptom Score (IPSS)

  1 month, 6 months, 12 months, 24 months

Other Outcomes (1)

• The occurrence of adverse events and device-related adverse events reported

  through out study

Study Arms (2)

HIFU

EXPERIMENTAL

Integrated Imaging High Intensity Focused Ultrasound using the Ablatherm Device

Device: Integrated Imaging High Intensity Focused Ultrasound

Cryotherapy

ACTIVE COMPARATOR

Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)

Device: Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy)

Interventions

Integrated Imaging High Intensity Focused Ultrasound DEVICE

Also known as: HIFU

HIFU

Endocare CRYOcare Cryosurgical and Galil Medical CRYO-HIT Systems (cryotherapy) DEVICE

Cryotherapy

Also known as: Endocare CRYOcare Cryosurgical, Galil Medical CRYO-HIT Systems (cryotherapy)

Cryotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• EDAP TMS S.A.: lead

Study Sites (15)

Chinn & Chinn Urology Associates

Arcadia, California, 91006, United States

Location

Univeristy of Colorado Hospital and Health Science Center

Aurora, Colorado, 80010, United States

Location

Florida Foundation for Healthcare Research Inc

Ocala, Florida, 34474, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Brooklyn Urology Research Group

Brooklyn, New York, 11215, United States

Location

Sloan-Kettering Institute

New York, New York, 10021, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2765, United States

Location

Urolgoy Associates of North Texas

Arlington, Texas, 76017, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77230, United States

Location

Virginia Urology Center

Richmond, Virginia, 23235, United States

Location

Medical College of Wisconsin, Inc.

Milwaukee, Wisconsin, 53226, United States

Location

Maple Leaf HIFU

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (1)

• Thuroff 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. doi: 10.1089/089277903322518699.

  PMID: 14622488 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Carey Robertson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2006
• First Posted: February 24, 2006
• Study Start: April 1, 2006
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2014
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

US (14); CA (1)