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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA014520 | U.S. NIH Grant/Contract | View source | |
| WCCC-CO-99802 | |||
| NCI-N01-CN-95130 | |||
| WCCC-CO-2000169 | |||
| NCI-P01-0188 | |||
| CDR0000068813 | Other Identifier | ||
| 2000-595 | Other Identifier | Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation, then prostatectomy | Placebo Comparator | Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy. |
|
| Doxercalciferol once daily for 28 days | Active Comparator | Dietary supplement once daily to treat prostate cancer for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxercalciferol | Dietary Supplement | Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intermediate endpoint biomarker modulation | 18 months | |
| Toxicity | 30 months |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| George Wilding, MD | University of Wisconsin, Madison | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States | ||
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C042533 | 1 alpha-hydroxyergocalciferol |
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|
| conventional surgery | Procedure | Procedure: Prostatectomy for prostate cancer |
|
|
| James P. Wilmot Cancer Center at University of Rochester Medical Center |
| Rochester |
| New York |
| 14642 |
| United States |
| Veterans Affairs Medical Center - Madison | Madison | Wisconsin | 53705 | United States |
| Meriter Hospital | Madison | Wisconsin | 53715 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226-3596 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |