Clinical trial NCT00295802: Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
Official title: Ablatherm Integrated Imaging High Intensity Focused Ultrasound for the Indication of Low Risk, Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Prostate Cancer
Keywords: Prostate Cancer
HIFU
EDAP
Low Risk, Localized Prostate Cancer
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 141
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Through 24 month period
Secondary outcomes:
measure: Achievement of a nadir PSA within 6 months < 0.5 ng/ml
timeFrame: 6 months
measure: Overall survival, defined as time to death due to any cause
timeFrame: From date of treatment until the date of death due to any cause
measure: Disease specific survival, defined as the time to death due to the underlying disease
timeFrame: "From date of treatment until the date of death due to the underlying cause
measure: Change from baseline in the University of California, Los Angeles Quality of Life (UCLA QOL)
timeFrame: 1 month, 6 months, 12 months, 24 months
measure: Change from baseline in the International Prostate Symptom Score (IPSS)
timeFrame: 1 month, 6 months, 12 months, 24 months
Other outcomes:
measure: The occurrence of adverse events and device-related adverse events reported
timeFrame: through out study
Locations:
city: Arcadia
country: United States
facility: Chinn & Chinn Urology Associates
state: California
city: Aurora
country: United States
facility: Univeristy of Colorado Hospital and Health Science Center
state: Colorado
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research Inc
state: Florida
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Brooklyn Urology Research Group
state: New York
city: New York
country: United States
facility: Sloan-Kettering Institute
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Urolgoy Associates of North Texas
state: Texas
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Inc.
state: Wisconsin
city: Hamilton
country: Canada
facility: Maple Leaf HIFU
state: Ontario
Study officials:
affiliation: Duke University
name: Carey Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.