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Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer Clinical research trials and Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer. Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "U" Clinical Trials Conditions > Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer  Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): EDAP Technomed ,
Synopsis: RATIONALE: Ultrasound therapy kills tumor cells by heating them to several degrees above body temperature. This treatment may be effective for prostate cancer. PURPOSE: Phase III trial to determine the effectiveness of ultrasound therapy in treating patients who have stage I or stage II prostate cancer that has recurred following radiation therapy.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 50 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SuzanneCourtney, Study Chair, EDAP Technomed
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Additional Information:
Study ID Numbers: CDR0000067682; EDAP-G980308,GUMC-99034
Study Start Date: July 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005075
Other Stage 1 Prostate Cancer Studies:
1. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
2. Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
3. Testosterone in Treating Patients With Progressive Prostate Cancer That No Longer Responds to Hormone Therapy
4. Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
5. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
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Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate Cancer
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