Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00022412
First received: August 10, 2001
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Prostate Cancer
Dietary Supplement: doxercalciferol
Procedure: conventional surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Intermediate endpoint biomarker modulation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2001
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Localized adenocarcinoma of the prostate

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022412

Locations
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Wisconsin
Meriter Hospital
Madison, Wisconsin, United States, 53715
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: George Wilding, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00022412     History of Changes
Other Study ID Numbers: CDR0000068813, P30CA014520, WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188
Study First Received: August 10, 2001
Last Updated: November 27, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Wisconsin, Madison:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014