Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: conventional surgery; Dietary supplement: doxercalciferol

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Observation, then prostatectomy; Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.	Procedure: conventional surgery; Procedure: Prostatectomy for prostate cancer; Other Names: Prostatectomy - no dietary supplement
Active Comparator: Doxercalciferol once daily for 28 days; Dietary supplement once daily to treat prostate cancer for 28 days	Dietary supplement: doxercalciferol; Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.; Other Names: Localized adenocarcinoma of the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intermediate endpoint biomarker modulation	18 months
Toxicity	30 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): February 1, 2006
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: August 10, 2001
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; 1 alpha-hydroxyergocalciferol
• Other Study ID Numbers: CO99802; P30CA014520 (U.S. NIH Grant/Contract); WCCC-CO-99802; NCI-N01-CN-95130; WCCC-CO-2000169; NCI-P01-0188; CDR0000068813 (Other Identifier); 2000-595 (Other Identifier: Institutional Review Board)