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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Active 50 and over Other G050103 NCT00295802

Trial Description

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.

Further Study Information

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 Criteria

Inclusion Criteria:

• Diagnosis of prostate cancer confirmed by PSA and prostate biopsy

• Male subjects, aged equal to or over 60 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, or other agents (e.g. saw palmetto) that affect PSA levels

• 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

EDAP Technomed, Incorporated

Carey Robertson, MD

Principal Investigator

Call Center

Ph: 866-650-4466

U.S.A.
California
	Arcadia
	Chinn & Chinn Urology Associates
		Douglas Chinn, MD	Principal Investigator
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		E. David Crawford, MD	Principal Investigator
		James Lugg, MD	Sub-Investigator
		Paul Maroni, MD	Sub-Investigator
Florida
	Daytona Beach
	Atlantic Urology Associates
		Martin Dineen, MD	Principal Investigator
	Ocala
	Florida Foundation for Healthcare Research
		Russell Locke, MD	Principal Investigator
		Ira Klimberg, MD	Sub-Investigator
		Rick Sessions, PA-C	Sub-Investigator
		Roger Madore, PA-C	Sub-Investigator
		William Smith, PA-C	Sub-Investigator
New Jersey
	Hackensack
	Hackensack University Medical Center Cancer Center
		Ihor Sawczuk, MD	Principal Investigator
		Ravi Munver, MD	Sub-Investigator
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		James Eastham, MD	Principal Investigator
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Cary Robertson, MD	Principal Investigator
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Stephen Jones, M.D.	Principal Investigator
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Dan Rukstalis, MD	Principal Investigator
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Edouard Trabulsi, M.D.	Principal Investigator
		Leonard Gomella, M.D.	Sub-Investigator
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Sam Chang, MD	Principal Investigator
		Michael S. Cookson	Sub-Investigator
Texas
	Arlington
	Urolgoy Associates of North Texas
		H. Patterson Hezmall, MD	Principal Investigator
	Houston
	M. D. Anderson Cancer Center at University of Texas
		John F Ward, MD	Principal Investigator
	Temple
	Scott and White Cancer Institute
		Belur Patel, MD	Principal Investigator
Virginia
	Richmond
	Virginia Urology - Stony Point
		Anthony Sliwinski, MD	Principal Investigator
		Charles Wadsworth, MD	Sub-Investigator
Canada
Ontario
	Hamilton
	Maple Leaf HIFU
		William Orovan, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00295802
Information obtained from ClinicalTrials.gov on July 28, 2008