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Home > "U" Clinical Trials Conditions > Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer  Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,recurrent prostate cancer
Status: Recruiting
Sponsor(s): Focus Surgery ,
Synopsis: 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 determine the effectiveness of focused ultrasound energy in treating patients who have locallyrecurrentprostate cancer.
Details: 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 (post-surgical 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 40 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed locally recurrent prostate cancer after prior surgery 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 - No prior brachytherapy for prostate cancer Surgery: - See Disease Characteristics - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelKoch, Study Chair, Indiana University Cancer Center
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patient Number Indiana University Cancer Center 317-630-6044
Additional Information:
Study ID Numbers: CDR0000069125; FOCUS-G000280,NCI-V01-1683,IUMC-010235
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030277
Other Recurrent Prostate Cancer Studies:
1. Doxorubicin and Strontium-89 With or Without Celecoxib in Treating Patients With Progressive Androgen-Independent Prostate Cancer and Bone Metastases
2. Brachytherapy in Treating Patients With Recurrent Prostate Cancer
3. Estramustine, Docetaxel, and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
4. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
5. BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
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