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

Phase 2/Phase 3
50 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.

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

- 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.

Type of Study:


Study Design:

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

Outcome 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

Principal Investigator

Carey Robertson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • HIFU
  • EDAP
  • Low Risk, Localized Prostate Cancer
  • Prostatic Neoplasms



Cleveland Clinic Foundation Cleveland, Ohio  44195
Hackensack University Medical Center Hackensack, New Jersey  07601
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Virginia Urology Center Richmond, Virginia  23230
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
Thomas Jefferson University Philadelphia, Pennsylvania  19107-6541
Urology Associates of Central CA Fresno, California  93720
The University of Texas M.D. Anderson Cancer Center Houston, Texas  
Scott & White Hospital Temple, Texas  76508
Chinn & Chinn Urology Associates Arcadia, California  91006
Univeristy of Colorado Hospital and Health Science Center Aurora, Colorado  80010
Florida Foundation for Healthcare Research Inc Ocala, Florida  34474
Brooklyn Urology Research Group Brooklyn, New York  11215
Sloan-Kettering Institute New York, New York  10021
Triangle Urology Pittsburgh, Pennsylvania  15212
Urolgoy Associates of North Texas Arlington, Texas  76017
Medical College of Wisconsin, Inc. Milwaukee, Wisconsin  53226