drugset / Trial / NCT00244920

Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer

NCT00244920

RandomizedOpen-labelTreatment

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide and bicalutamide, may stop the adrenal glands from making androgens. Squalamine lactate may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving hormone therapy together with squalamine lactate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving hormone therapy together with squalamine lactate works compared to hormone therapy alone in treating patients who are undergoing a radical prostatectomy for locally advanced prostate cancer.

Timeline

Start
2002-01
Primary completion
2007-06
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Squalamine Unknown Intravenous
Background Bicalutamide Other / unclassified Oral
Background Leuprolide Other / unclassified Intramuscular

Indications