NCT01344564
Completed
Not Applicable
Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
ConditionsProstate Cancer
InterventionsDegarelix acetate, Leuprolide acetate
Overview
- Phase
- Not Applicable
- Intervention
- Degarelix acetate, Leuprolide acetate
- Conditions
- Prostate Cancer
- Sponsor
- Urology of Virginia
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Testosterone measurement
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
ADT
All subjects receive ADT, degarelix acetate for 3 months followed by one 3 month leuprolide depot.
Intervention: Degarelix acetate, Leuprolide acetate
Outcomes
Primary Outcomes
Testosterone measurement
Time Frame: 11 times over 6 months
Study Sites (1)
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