Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide
Not Applicable
Completed
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT01344564
- Lead Sponsor
- Urology of Virginia
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ADT Degarelix acetate, Leuprolide acetate All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.
- Primary Outcome Measures
Name Time Method Testosterone measurement 11 times over 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States