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Evaluation of the Ablatherm High Intensity Focused Ultrasound Device After Failed Radiation Therapy for Localized Prostate Cancer

Phase 3
50 Years
Not Enrolling
Prostate Cancer

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Trial Information

Evaluation of the Ablatherm High Intensity Focused Ultrasound Device After Failed Radiation Therapy for Localized Prostate Cancer

OBJECTIVES: I. Determine the effectiveness of the Ablatherm high-intensity focused
ultrasound device in providing control of disease for at least 12 months after treatment in
patients with stage I or II prostate cancer recurring after external beam radiotherapy. II.
Determine the safety of this treatment device in these patients.

OUTLINE: This is an open-label, multicenter study. A probe is inserted into the rectum.
Ultrasound energy is then delivered through probe to prostate tissue over 2-3 hours. Quality
of life is assessed at study initiation; at 14 days and 3, 6, and 12 months; and then
annually thereafter. Patients are followed at 14 days; at 3, 6, 9, and 12 months; and then
annually thereafter.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage I or II prostate cancer Organ
confined (T1 or T2) At least 1 current positive biopsy Failed prior external beam
radiotherapy for T1-T2 prostate cancer within last 18 months (with no worsening of the
cancer in the first 12 months after radiotherapy) PSA nadir less than 4 ng/mL after
external beam radiotherapy If prior hormonal therapy, PSA must be greater than 1.0 ng/mL
and testosterone level normal after therapy Prostate volume no greater than 35 g, or 35-50
g if maximum anterior posterior diameter no greater than 2.5 cm Kattan Nomogram at least
.50 60-month recurrence-free probability prior to external beam radiotherapy ASA
Classification 1-3 No lymph node involvement by CT scan No metastases No prostate seroma,
prostate abscess, or active prostatitis Must meet the following conditions: No artificial
sphincter, penile prosthesis, or intraprostatic implant such as stent or catheter Normal
rectal anatomy and rectal mucosa Rectal wall measurement no greater than 6 mm with
treatment probe in place No calcification inducing a shadow in the prostate that would
preclude study No significant rectal or bladder morbidity after radiotherapy (RTOG/EORTC
rectal or bladder scores at least 2) No rectal fibrosis, stenosis, fistula, disease, or
other rectal anomalies that would make rectal probe insertion difficult

PATIENT CHARACTERISTICS: Age: 50 and over Performance status: Not specified Life
expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal:
Creatinine greater than 1.8 mg/dL No prior superficial bladder cancer, urethral stricture,
or bladder neck contracture No active urinary tract infection No upper urinary tract
disease No compromised renal function No urinary tract fistula No urethral stenosis Other:
No inflammatory bowel disease No interest in future fertility No prior HIV infection,
AIDS, or other immunosuppression No known latex hypersensitivity Mentally coherent and
capable of completing symptom and quality of life questionnaires No prior or concurrent
illness or surgery that would preclude study or follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: See Disease Characteristics At least 6 months since prior hormonal
therapy Radiotherapy: See Disease Characteristics No more than 10 permanent radioactive
seed implants Less than 1 cm from prostate apex or less than 1.2 cm from rectal wall
Surgery: At least 6 weeks since prior transurethral resection of the prostate or other
prostate surgery No prior rectal surgery except hemorrhoidectomy Other: No definitive
local treatment for prostate cancer since completion of external beam radiotherapy At
least 2 months since prior finasteride or other agents that affect PSA (e.g., saw
palmetto) At least 3 months since prior benign prostatic hypertrophy thermotherapy or
hyperthermia treatment At least 30 days since prior investigational drug or device No
concurrent participation in another clinical trial

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Suzanne Courtney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

EDAP Technomed


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • recurrent prostate cancer
  • Prostatic Neoplasms



Baylor College of Medicine Houston, Texas  77030
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128