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Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate Clinical research trials and Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate. Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate clinical trial. Test subjects typically receive the most expert healthcare available for their Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "U" Clinical Trials Conditions > Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate  Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
For Condition: stage 2 prostate cancer,stage 1 prostate cancer
Status: No longer 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 study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 40 Years/80 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelKoch, Study Chair, Indiana Cancer Pavilion
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Additional Information:
Study ID Numbers: CDR0000069126; FOCUS-G000276,NCI-V01-1684,IUMC-010233,CWRU-050130
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030290
Other Stage 2 Prostate Cancer Studies:
1. Calcitriol and Zoledronate in Treating Patients With Progressive Prostate Cancer
2. Vaccine Therapy Plus QS21 in Treating Patients With Progressive Prostate Cancer
3. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
4. Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse
5. Assessing Quality of Life of Patients With Prostate Cancer
Related Studies:
Other stage 2 prostate cancer Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate
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