Conditions: Prostatic Neoplasms
Keywords: Prostate Neoplasm Cancer Carcinoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 137
Healthy volunteers: no

Brief summary:
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.

Detailed description:
This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.

Arms:
arm 1: All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.

Interventions: intervention 1: Leuprolide Mesylate
Intervention descriptions: intervention 1: Subcutaneous injection of 50mg Leuprolide Mesylate

Protocol document: