Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
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Purpose
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Procedure: high-intensity focused ultrasound ablation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System |
| Study Start Date: | October 2001 |
| Study Completion Date: | February 2006 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with organ-confined prostate cancer.
OUTLINE: This is a multicenter study.
A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken at least 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU.
Patients are followed at 2, 14, 30, 90, and 180 days.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically confirmed organ-confined prostate cancer (clinical stage T1 or T2 only)
- Pretreatment prostate weight less than 40 g
- Gleason score no greater than 7
- PSA no greater than 10 ng/mL
- No significant intravesical median lobe (greater than 2 cm) on ultrasound
- Able to visualize prostate gland adequately on transrectal ultrasound imaging
- No prostate calcification greater than 5 mm
- No metastases by bone scan
PATIENT CHARACTERISTICS:
Age:
- 40 to 80
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No bleeding disorder as determined by abnormal PT and PTT
Renal:
- No active urinary tract infection
- No history of urinary bladder neck contracture
Other:
- No prior allergy to latex
- No Anesthesia Surgical Assignment category IV or greater
- No interest in future fertility
- No history of inflammatory bowel disease
- No other concurrent major debilitating illness
- No other prior or concurrent malignancy except skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy for prostate cancer
Chemotherapy:
- No prior chemotherapy for prostate cancer
Endocrine therapy:
- At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer
Radiotherapy:
- No prior radiotherapy for prostate cancer
Surgery:
- No prior transurethral resection of prostate
- No prior urethral stent
- No prior major rectal surgery
Other:
- No prior cryotherapy for prostate cancer
- No prior thermotherapy
- No other prior therapy for prostate cancer
- No concurrent warfarin or other anticoagulant
Contacts and Locations| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Study Chair: | Michael O. Koch, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00030290 History of Changes |
| Other Study ID Numbers: | FOCUS-G000276, CDR0000069126, CWRU-050130, IUMC-010233, NCI-V01-1684 |
| Study First Received: | February 14, 2002 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013