Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage I Prostate Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
Given IV
PROCEDUREconventional surgery
Undergo surgery
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage I or II (T1-2) carcinoma of the prostate * PSA greater than 8 ng/mL * Abnormal findings on digital rectal examination * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average doubling time between low and high volume tumors | Up to 3 years |
Countries
United States
Outcome results
None listed