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| ID | Type | Description | Link |
|---|---|---|---|
| 98-374 | |||
| CDR0000066989 | Registry Identifier | PDQ (Physician Data Query) |
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Phase II trial to study the effectiveness of broxuridine in treating patients who are undergoing surgery for stage I or stage II prostate cancer. Broxuridine may help doctors determine the rate of growth of prostate tumors and help them plan effective treatment
OBJECTIVES:
I. Measure the potential doubling times of multifocal adenocarcinomas of the prostate using broxuridine.
II. Determine whether the doubling times of multifocal carcinomas occurring within a single prostate are consistent with a model in which low-volume carcinomas have slow doubling times and high-volume carcinomas have fast doubling times.
OUTLINE:
Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate. Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (bromodeoxyuridine) | Experimental | Patients receive broxuridine IV over 30 minutes on day -1. Approximately 12-96 hours later, patients undergo surgery to remove the prostate.Tumor tissue is examined by immunostaining for the presence of broxuridine to determine doubling times of the tumor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bromodeoxyuridine | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Average doubling time between low and high volume tumors | Up to 3 years |
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Inclusion Criteria:
Diagnosis of stage I or II (T1-2) carcinoma of the prostate
Eligible for radical prostatectomy
Performance status - ECOG 0 or 1
No prior biologic therapy
No prior chemotherapy
No prior neoadjuvant hormonal therapy
No prior radiotherapy
See Disease Characteristics
No prior therapy that would affect tumor growth rates or volume
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| Name | Affiliation | Role |
|---|---|---|
| Leonard Glode | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Denver | Colorado | 80217-3364 | United States |
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| conventional surgery | Procedure | Undergo surgery |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001973 | Bromodeoxyuridine |
| C006824 | 5-bromouridine |
| D013514 | Surgical Procedures, Operative |
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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