- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030277
High-Intensity Focused Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Feasibility Study for Locally Recurrent Prostate Cancer Treatment With HIFU Using the SONABLATE System
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase I trial is studying focused ultrasound energy to see how well it works in treating patients with locally recurrent prostate cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the ability of Sonablate to focus ultrasound 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 locally recurrent prostate cancer.
OUTLINE: Patients are stratified according to prior treatment failure (brachytherapy vs post-external beam radiotherapy).
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 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken 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 (10 per stratum) will be accrued for this study.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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-
New York
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Brooklyn, New York, United States, 11201
- Long Island College Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed locally recurrent prostate cancer after prior brachytherapy or external-beam radiotherapy for initial diagnosis of organ-confined disease (clinical stage T1 or T2 only)
- Prostatic fossa biopsy positive for cancer cells
- Gleason score no greater than 7
- PSA levels 0.5-10 ng/mL
- Able to adequately visualize local recurrence 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 (ASA) category IV or greater
- No interest in future fertility
- No history of inflammatory bowel disease
- No other concurrent major nonmalignant 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:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
- No prior radical prostatectomy
- No prior transurethral resection of prostate
- No prior urethral stent
- No prior major rectal surgery
Other:
- No prior thermotherapy
- No other prior therapy for prostate cancer
- No concurrent warfarin or other anticoagulant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FOCUS-G000280
- CDR0000069125 (Registry Identifier: PDQ (Physician Data Query))
- IUMC-010235
- NCI-V01-1683
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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