Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

Study Overview
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Brief Summary
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The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.

Detailed Description
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This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.

Official Title
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An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Leuprolide Mesylate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged ≥ 18 years old Males with histologically confirmed carcinoma of the prostate Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy Baseline morning serum testosterone level > 150 ng/dL performed at Screening Visit Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2 Life expectancy of at least 18 months Laboratory values Absolute neutrophil count ≥ 1,500 cells/µL Platelets ≥ 100,000 cells/µL Hemoglobin ≥ 10 gm/dL Total bilirubin ≤ 1.5 × upper limit of normal (ULN) AST (SGOT) ≤ 2.5 × ULN ALT (SGPT) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 mg/dL Lipid profile within acceptable range according to investigator's opinion Serum glucose within acceptable range according to investigator's opinion HgbA1c within acceptable range according to investigator's opinion Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment Serum glucose within acceptable range according to investigator's judgement Urinalysis within normal range according to the investigator's judgment Agree to use male contraceptive methods during study trial Based on the Investigator's judgment, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol All aspects of the protocol explained and written informed consent obtained Exclusion Criteria: Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study. Receipt of any vaccination (including influenza) within 4 weeks of screening visit History of blood donation within 2 months of screening visit History of anaphylaxis to any LH-RH analogues Receipt of any LHRH suppressive therapy within 6 months of screening visit Major surgery, including any prostatic surgery, within 4 weeks of screening visit History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and subjects at risk for spinal cord compression Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction History of bilateral orchiectomy, adrenalectomy, or hypophysectomy History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator History of drug and/or alcohol abuse within 6 months of Baseline Contraindication to leuprolide or an LHRH agonist as indicated on package labeling Use of 5-alpha reductase inhibitor within the last 6 months of screening visit History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are required. Prostate cancer subjects with poor controlled diabetes mellitus with Hb1Ac > 9.5% or urine glycosuria > 1.0 g/dL should be excluded. Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens Use of any investigational agent within 4 weeks of screening visit Use of any over-the-counter (OTC) medication within 4 weeks of screening visit except for those listed in the permitted Concomitant Treatment section. Uncontrolled intercurrent illness that would jeopardize the subject's safety, interfere with the objectives of the protocol, or limit the subject's compliance with study requirements, as determined by the Investigator in consultation with the Sponsor

Ages Eligible for Study
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Minimum Age: 18 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leuprolide Mesylate 25mg<br>All subjects will be males with prostate cancer. They will be injected twice with a depot formulation containing 25 mg of Leuprolide Mesylate. The first dose on day 0 and the second dose on day 84 (twelve weeks apart). Subjects will be followed until day 168. | Drug: Leuprolide Mesylate<br>* Subcutaneous injection of 25mg Leuprolide Mesylate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Leuprolide Mesylate (LMIS 25mg) | The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (≤ 50 ng/dL) from Day 28 through Day 168. | 168 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs). | 168 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Neoplasm Cancer Carcinoma