RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer	Drug: doxercalciferol  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: conventional surgery  Procedure: surgery	Phase II

Further Study 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, open-label, 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.

Ages Eligible for Study:  21 Years and above,  Genders Eligible for Study:  Both

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

Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
New York
      James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester,  New York,  14642,  United States; Recruiting
Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226-3596,  United States; Recruiting
      Meriter Hospital, Madison,  Wisconsin,  53715,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States; Recruiting
      Veterans Affairs Medical Center - Madison, Madison,  Wisconsin,  53705,  United States; Recruiting

Study chairs or principal investigators

George T. Wilding, MD,  Study Chair,  University of Wisconsin Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068813; WCCC-CO-99802; NCI-N01-CN-95130; WCCC-CO-2000169; NCI-P01-0188; NCT00022412
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  August 10, 2001
ClinicalTrials.gov Identifier:  NCT00022412
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08