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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00295802
• Other study ID #: G050103
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: February 22, 2006
• Last updated: February 6, 2014
• Start date: April 2006
• Est. completion date: September 2014

Study information

• Verified date: February 2014
• Source: EDAP TMS S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 141
• Est. completion date: September 2014
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Integrated Imaging High Intensity Focused Ultrasound

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

Locations

Country	Name	City	State
Canada	Maple Leaf HIFU	Hamilton	Ontario
United States	Chinn & Chinn Urology Associates	Arcadia	California
United States	Urolgoy Associates of North Texas	Arlington	Texas
United States	Univeristy of Colorado Hospital and Health Science Center	Aurora	Colorado
United States	Brooklyn Urology Research Group	Brooklyn	New York
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Duke University Medical Center	Durham	North Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Medical College of Wisconsin, Inc.	Milwaukee	Wisconsin
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Sloan-Kettering Institute	New York	New York
United States	Florida Foundation for Healthcare Research Inc	Ocala	Florida
United States	Virginia Urology Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
EDAP TMS S.A.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The occurrence of adverse events and device-related adverse events reported		through out study	Yes
Primary	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	No
Secondary	Achievement of a nadir PSA within 6 months < 0.5 ng/ml		6 months	No
Secondary	Overall survival, defined as time to death due to any cause		From date of treatment until the date of death due to any cause	No
Secondary	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	No
Secondary	Change from baseline in the University of California, Los Angeles Quality of Life (UCLA QOL)		1 month, 6 months, 12 months, 24 months	No
Secondary	Change from baseline in the International Prostate Symptom Score (IPSS)		1 month, 6 months, 12 months, 24 months	No