The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
164
45 mg Intramuscular injection 6 month depot formulation
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
Time frame: Day 32 through Week 52
Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit
Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).
Time frame: Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit
Change from baseline in prostate specific antigen (PSA).
Time frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Change from baseline in prostatic acid phosphatase (PAP).
Time frame: Weeks 1, 12, 26, 40, 52 and Final Visit
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