Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in: achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Official Title
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A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Triptorelin embonate 22.5 mg


Participation Criteria
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Eligibility Criteria
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Summary Inclusion Criteria: Meets protocol-specified criteria for qualification and contraception Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures Summary Exclusion Criteria: Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
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: Triptorelin embonate 22.5 mg<br>Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. | Drug: Triptorelin embonate 22.5 mg<br> <br> * Other names: Pamorelin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L) |  | within 337 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169 |  | on Days 1 and 169 | 
| Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337 |  | Baseline through Day 337 | 
| Number of Participants Who Presented a Real Acute-on-chronic (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated) |  | Day 171 | 
| Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC) |  | Days 1-169 | 
| Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax) |  | Days 1-169 | 
| Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax) |  | Days 1-169 | 
| Testosterone PD Metrics for First Injection: Time to Castration (Tcast) |  | Days 1-169 | 
| Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC) |  | Days 1-169 and Days 169-337 | 
| Triptorelin PK Metrics for Both Injections: Cmax |  | Days 1-169 and Days 169-337 | 
| Triptorelin PK Metrics for Both Injections: Concentration 0 Hour |  | Days 1-169 and Days 169-337 |