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Doxercalciferol Before Surgery in Treating Localized Prostate Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Doxercalciferol Before Surgery in Treating Localized Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Doxercalciferol Before Surgery in Treating Localized Prostate Cancer Clinical research trials and Doxercalciferol Before Surgery in Treating Localized Prostate Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Doxercalciferol Before Surgery in Treating Localized Prostate Cancer. Doxercalciferol Before Surgery in Treating Localized Prostate Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Doxercalciferol Before Surgery in Treating Localized Prostate Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Doxercalciferol Before Surgery in Treating Localized Prostate Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Doxercalciferol Before Surgery in Treating Localized Prostate Cancer Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
For Condition: stage 2 prostate cancer,stage 1 prostate cancer,adenocarcinoma of the prostate
Status: Recruiting
Sponsor(s): University of Wisconsin Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Doxercalciferol may be an effective way to treat localizedprostate cancer before surgery. PURPOSE: Randomizedphase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
Details: OBJECTIVES: - Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer. - Assess the toxicity of this drug in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms. - Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy. - Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed localized adenocarcinoma of the prostate - Candidate for prostatectomy PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - WBC at least 4,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.4 mg/dL - AST no greater than 3 times normal Renal: - Creatinine no greater than 2.0 mg/dL - Calcium no greater than 10.2 mg/dL - No idiopathic urinary calcium stone disease PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - No prior hormonal therapy for prostate cancer - No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins Radiotherapy: - No prior brachytherapy or external beam radiotherapy for prostate cancer Surgery: - See Disease Characteristics Other: - At least 7 days since prior vitamin D therapy or calcium supplements - No other concurrent vitamin D analogues or calcium supplements - No concurrent magnesium-containing antacids - No concurrent thiazide-containing diuretics - No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeWilding, Study Chair, University of Wisconsin Comprehensive Cancer Center
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting William See 414-456-6950
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting George Wilding 608-263-8610
Additional Information:
Study ID Numbers: CDR0000068813; NCI-N01-CN-95130,WCCC-CO-2000169,NCI-P01-0188,WCCC-CO-99802
Study Start Date:
Record last reviewed: October 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022412
Other Adenocarcinoma Of The Prostate Studies:
1. Behavior-Based Dietary Intervention in Treating Patients With Hormone-Refractory Prostate Cancer
2. Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
3. Ultrasound in Treating Patients With Locally Recurrent Prostate Cancer
4. Hormone Therapy With or Without Mitoxantrone and Prednisone in Treating Patients Who Have Undergone Radical Prostatectomy for Prostate Cancer
5. Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Wisconsin Clinical Trials
Other Milwaukee Clinical Trials
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
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