This trial is active, not recruiting.

Condition prostate cancer
Treatments doxercalciferol, conventional surgery
Phase phase 2
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date August 2001
End date February 2006
Trial size 60 participants
Trial identifier NCT00022412, 2000-595, CDR0000068813, NCI-N01-CN-95130, NCI-P01-0188, P30CA014520, WCCC-CO-2000169, WCCC-CO-99802


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Placebo Comparator)
Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
conventional surgery Prostatectomy - no dietary supplement
Procedure: Prostatectomy for prostate cancer
(Active Comparator)
Dietary supplement once daily to treat prostate cancer for 28 days
doxercalciferol Localized adenocarcinoma of the prostate
Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.

Primary Outcomes

Intermediate endpoint biomarker modulation
time frame: 18 months
time frame: 30 months

Eligibility Criteria

Male participants from 21 years up to 120 years old.

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

Additional Information

Official title Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
Description 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 one 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.