Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Leuprolide acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of prostate cancer Need for androgen deprivation treatment for 1 year Serum testosterone level ≥ 150 ng/dL Life expectancy of at least 18 months ECOG Performance status grades 0,1 or 2 Exclusion Criteria: Hypersensitivity to leuprolide acetate or polylactic acid History of bilateral orchiectomy, adrenalectomy, or hypophysectomy History of hypogonadism
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Leuprolide acetate<br>* 45 mg Intramuscular injection 6 month depot formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects. |  | Day 32 through Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status. |  | 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). |  | 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). |  | Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit | 
| Change from baseline in prostatic acid phosphatase (PAP). |  | Weeks 1, 12, 26, 40, 52 and Final Visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leuprolide, Prostatic Neoplasms, Testosterone, Prostate-specific Antigen, Pharmacokinetics, luprolide acetate