Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: conventional surgery; Dietary Supplement: doxercalciferol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00022412

CO99802

CDR0000068813 (Other Identifier)

P30CA014520 (U.S. NIH Grant/Contract)

NCI-N01-CN-95130

WCCC-CO-99802

2000-595 (Other Identifier)

NCI-P01-0188

WCCC-CO-2000169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 21 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Observation, then prostatectomy

Placebo Comparator group

Description:

Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

Treatment:

Procedure: conventional surgery

Doxercalciferol once daily for 28 days

Active Comparator group

Description:

Dietary supplement once daily to treat prostate cancer for 28 days

Treatment:

Dietary Supplement: doxercalciferol