drugset / Trial / NCT00223665

Effects of IAS in Men With Localized Biochemical Relapsed Prostate Cancer

NCT00223665

Phase 2 Completed 102 enrolled University of Washington Sanofi · collab
NaSingle-groupOpen-labelTreatment

Summary

This study was a prospective analysis in men with localized prostate cancer who had rising Prostate Specific Antigen (PSA) levels after definitive treatment with surgery or radiation. Patients received Intermittent Androgen Suppression (IAS) in 9 month cycles until they became metastatic, became castrate resistant, or withdrew from the study. Subjects were monitored for time to development of Castration Resistant Prostate Cancer (CRPC) and overall survival. They were also monitored for the impact of IAS on a variety of neuro-psychiatric assessments and on bone density.

Timeline

Start
1997-01-08
Primary completion
2012-09-06
Completion
2012-09-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Leuprolide Other / unclassified 7.5 mg Intramuscular
Subject flutamide Small molecule 250 mg Oral

Indications