At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Screening Trial of Enzalutamide/MDV-3100 and LHRH Analogue vs Combined Androgen Deprivation (LHRH Analogue + Bicalutamide) in Metastatic Hormone Sensitive Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating enzalutamide, bicalutamide, and 4 other interventions for Adenocarcinoma of the Prostate and 2 related conditions. Completed, enrolled 71 participants across 4 sites.
Detailed Summary
This randomized phase II trial studies if enzalutamide added to standard luteinizing hormone-releasing hormone (LHRH) analogue therapy will improve effects against prostate cancer compared to the standard therapy of LHRH analogue and bicalutamide. Hormone therapies stop the body from producing or block the effect of male sex hormones (testosterone). Enzalutamide blocks the effect of male sex hormones which are responsible for the growth of prostate cancer. Hormonal therapies that lower the level of testosterone are among the most effective treatments for prostate cancer that have spread to other areas of the body (metastasized). It is not yet known whether LHRH analogue therapy with bicalutamide is more effective than LHRH analogue therapy with enzalutamide in treating prostate cancer.
Study Details
Timeline
Interventions
Given PO
Given PO
Undergo orchiectomy or receive LHRH analogue therapy
Undergo orchiectomy or receive LHRH analogue therapy
Undergo orchiectomy or receive LHRH analogue therapy
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