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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

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