drugset / Trial / NCT01163084

Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer

NCT01163084

Phase 1/2 Terminated 10 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase I/II trial studies giving leuprolide acetate or goserelin acetate together with or without vismodegib followed by surgery to see how well they work in treating patients with prostate cancer that has spread from where it started to nearby tissue or lymph nodes. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate or goserelin acetate, may lessen the amount of androgens made by the body. Vismodegib may slow the growth of tumor cells. Giving antihormone therapy together with vismodegib may be an effective treatment for prostate cancer.

Timeline

Start
2010-07-09
Primary completion
2012-06-01
Completion
2012-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Vismodegib Small molecule Oral
Background Goserelin Other / unclassified Subcutaneous
Background Leuprolide Other / unclassified Intramuscular