Clinical trial · Interventional
Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer
Cell Kinetic Study of Bromodeoxyuridine (BrdU) in Prostate Cancer
NCT00003832CI-TRIAL-00009145completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bromodeoxyuridine | Drug | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (bromodeoxyuridine)
- description
- 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.
- interventionNames
- Drug: bromodeoxyuridine
- Procedure: conventional surgery
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Average doubling time between low and high volume tumors
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.