Broxuridine Plus Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Treatments: Procedure: conventional surgery; Other: laboratory biomarker analysis; Drug: bromodeoxyuridine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00003832

NCI-2012-02297

98-374

CDR0000066989 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Treatment (bromodeoxyuridine)

Experimental group

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.

Treatment:

Drug: bromodeoxyuridine

Other: laboratory biomarker analysis

Procedure: conventional surgery