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Brachytherapy in Treating Patients With Recurrent Prostate Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Brachytherapy in Treating Patients With Recurrent Prostate Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Brachytherapy in Treating Patients With Recurrent Prostate Cancer Clinical research trials and Brachytherapy in Treating Patients With Recurrent Prostate Cancer health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Brachytherapy in Treating Patients With Recurrent Prostate Cancer. Brachytherapy in Treating Patients With Recurrent Prostate Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Brachytherapy in Treating Patients With Recurrent Prostate Cancer clinical trial. Human subjects often get the best healthcare available for their Brachytherapy in Treating Patients With Recurrent Prostate Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Brachytherapy in Treating Patients With Recurrent Prostate Cancer  Brachytherapy in Treating Patients With Recurrent Prostate Cancer
Brachytherapy in Treating Patients With Recurrent Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer,stage 3 prostate cancer,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): Center for Molecular Medicine ,
Synopsis: RATIONALE: Radiation therapy uses high-energy radiation to damage tumor cells. Brachytherapy uses radioactive material that is placed directly into or near the tumor. Brachytherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy.
Details: OBJECTIVES: I. Determine the dosimetry and toxicity of interstitial colloidal phosphorus P32 (cP32) in patients with locally recurrent prostate cancer that has failed conventional therapy. II. Determine the maximum tolerated dose of interstitial cP32 when combined with interstitial macroaggregated albumin (infusional brachytherapy) in these patients. III. Determine the therapeutic response rate to acceptable single doses of cP32 in these patients. PROTOCOL OUTLINE: This is a dose escalation study of colloidal phosphorus P32 (cP32). Patients receive cP32 and macroaggregated albumin via interstitial infusion using ultrasound localization. Cohorts of 3 patients receive escalating doses of cP32 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 4 patients experience dose limiting toxicities. Additional patients are treated at the MTD. Patients are followed at 1, 2, 4, and 6 weeks; then at 2, 4, 8, 12, 16, 20, and 24 months; and then every 6 months thereafter until death. PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for phase I of the study and a total of 40 patients will be accrued for phase II of the study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven locally recurrent prostate cancer that has failed conventional therapy (i.e., external beam radiotherapy, radioactive seed implants, and hormonal therapy); Must be confirmed clinically with elevated PSA and/or ultrasound; Prostates between 2-5 cm in diameter (i.e., volumes of 4-65 cm3) preferred; Prostates greater than 5 cm allowed, but 2 needles required for good distribution of study drug - No clinical/radiographic evidence of metastatic disease - No history of injury to urethra, bladder, or rectum --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: See Disease Characteristics - Radiotherapy: See Disease Characteristics - Surgery: Not specified --Patient Characteristics-- - Age: 21 and over - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Neutrophil count at least 1,900/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL (transfusion allowed) - Hepatic: Not specified - Renal: Blood urea nitrogen no greater than 25 mg/dL; Creatinine no greater than 1.5 mg/dL
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WayneCourt, Study Chair, Center for Molecular Medicine
Center for Molecular Medicine
Garden City, New York, 11530
United States
Additional Information:
Study ID Numbers: CDR0000067749; NCI-V00-1585,CMM-99025
Study Start Date: November 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005939
Other Stage 3 Prostate Cancer Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
2. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
3. Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer
4. Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer
5. Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other New York Clinical Trials
Other Garden City Clinical Trials
Brachytherapy in Treating Patients With Recurrent Prostate Cancer
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