Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no "testosterone surge" after leuprolide injection.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Urology of Virginia
• Collaborator: Ferring Pharmaceuticals
• Treatments: Androgens; Leuprolide

Criteria

Inclusion Criteria:

• 18 years or older

• Histologically confirmed adenocarcinoma of the prostate

• Androgen deprivation therapy is indicated

Exclusion Criteria:

• Baseline screening serum testosterone <150ng/dL

• Eastern Cooperative Oncology Group (ECOG) score > 2

• Diagnosed spinal or brain metastases

• Hormonal manipulation within previous 6 months