Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Wisconsin, Madison
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
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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
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 May 22, 2013