Trial Information
Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Testosterone measurement
Outcome Time Frame:
11 times over 6 months
Safety Issue:
No
Principal Investigator
Robert Given, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Urology of Virginia
Authority:
United States: Institutional Review Board
Study ID:
UVA002
NCT ID:
NCT01344564
Start Date:
April 2011
Completion Date:
August 2012
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Hormone therapy
- Testosterone measures
- Prostatic Neoplasms
Name | Location |
Urology of Virginia |
Newport News, Virginia 23606 |