Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate

Study Overview
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Brief Summary
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The main aim of this study is to assess the effectiveness and safety of the 6-month formulation of triptorelin pamoate in Chinese participants with locally advanced or metastatic cancer of the prostate. Participants will receive 1 injection of triptorelin pamoate 6-month formulation.

Official Title
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A Multicentre, Open-label, Single-arm Study to Investigate the Efficacy and Safety of Triptorelin Pamoate 22.5 mg 6-month Formulation in Chinese Patients With Locally Advanced or Metastatic Prostate Cancer

Conditions
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Advanced Prostate Cancer, Metastatic Prostate Cancer, Locally Advanced Prostate Cancer

Intervention / Treatment
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* Drug: Triptorelin pamoate (embonate) salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Participant is capable of giving signed informed consent Participant must be over 18 years of age, at the time of signing the informed consent. Has a histologically or cytologically confirmed adenocarcinoma, locally advanced or metastatic prostate cancer. Or participant has PSA recurrence after curative treatment and be a candidate for androgen deprivation therapy (ADT). Has serum testosterone level >150 ng/dL (> 5.2 nmol/L). Has expected survival time ≥12 months according to the investigator's assessment. Has Eastern Cooperative Oncology Group (ECOG) performance status score ≤1 Exclusion Criteria : Risk of a serious complication in the case of tumour flare Presence of another neoplastic lesion or brain metastases. Previous history of QT prolongation or concomitant use of medicinal products known to prolong the QT interval or with a known risk of torsades de pointes as per Pharmacovigilance Risk Assessment Committee (PRAC) recommendations. Metastatic hormone-sensitive prostate cancer with high tumour burden. Metastatic castration-resistant prostate cancer. Previous surgical castration. Previous hormone therapy (including abiraterone) for prostate cancer within 6 months prior to study start. Previous cytotoxic chemotherapy treatment within 6 months prior to study start. Use of finasteride or dutasteride within 2 months prior to study start Previous hypophysectomy or adrenalectomy Any current use or use within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and antiandrogens. Systemic or inhaled corticosteroids (topical application permitted). Any previous use of traditional Chinese medicine or herbal products within 1 month prior to study screening or planned use during the study of products, which are known to have cytotoxic effect or affect the metabolism and/or secretion of androgenic hormones Participation in another study with an investigational drug or treatment within 3 months prior to study entry or within 5 drug half-lives of the investigational drug (whichever is the longer). Severe kidney or liver impairment (creatinine >2 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x ULN). Any concomitant disorder or resulting therapy that is likely to interfere with participant compliance, the i.m. administration of the drug or with the study in the opinion of the investigator. Known hypersensitivity to triptorelin or any of its excipients, GnRH, other GnRH agonist/analogues. Known active use of recreational drug or alcohol dependence in the opinion of the investigator.

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: Triptorelin pamoate 22.5 mg 6-month formulation<br>All enrolled participants will receive one intramuscular (i.m.) injection of containing 22.5 mg 6-month formulation triptorelin pamoate on Day 1. | Drug: Triptorelin pamoate (embonate) salt<br>* Triptorelin pamoate 22.5 mg (6-month formulation), i.m. injection, single dose on Day 1.<br>* Other names: Dipherelin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving castrate levels of serum testosterone (<50 ng/dL or 1.735 nmol/L) |  | Day 29 | 
| Percentage of participants maintaining the castrate levels |  | From Week 8 to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse event (TEAEs) (including local tolerability) |  | From baseline up to Week 24 | 
| Actual values and changes from baseline in clinical laboratory tests | Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator. | At Week 24 | 
| Actual values and changes from baseline in physical examination | Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator. | At Day 1, Week 12 and Week 24 | 
| Percentages of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings | Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator. | At Week 4 and Week 24 | 
| Change from baseline in vital signs measurements | Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator. | At each visit up to Week 24 | 
| Percent change in prostate specific antigen (PSA) from baseline (prior to injection) | Percent change in PSA is defined as the absolute value of difference between the PSA values and the baseline value divided by the baseline value | At Week 12 and Week 24 | 
| Pharmacokinetics (PK) of Triptorelin: Time to Maximum Observed Drug Concentration (Tmax) | Tmax will be recorded from the PK blood samples collected. | Up to 24 weeks | 
| PK of Triptorelin: Maximum Observed Plasma (peak) Drug Concentration (Cmax) | Cmax will be recorded from the PK blood samples collected. | Up to 24 weeks | 
| PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Visit on Day 169 (AUC0-169) | AUC0-169 will be recorded from the PK blood samples collected. | up to Day 169 | 
| PK of Triptorelin: Area under the Plasma Concentration Time Curve From Zero to the Time 0 to the Last Quantifiable Concentration (AUClast) | AUClast will be recorded from the PK blood samples collected. | Up to 24 weeks | 
| Pharmacodynamics (PD) of Testosterone: Maximum Observed Plasma (peak) Drug Concentration (Cmax) | Cmax will be recorded from the PD blood samples collected. | Up to 24 weeks | 
| PD of Testosterone: Time to Maximum Observed Drug Concentration (Tmax) | Tmax will be recorded from the PD blood samples collected. | Up to 24 weeks | 
| PD of Testosterone: Time to Castration(Tcast) | Tcast will be recorded from the PD blood samples collected. | Up to 24 weeks | 
| Sparse plasma concentrations of triptorelin |  | At pre-dose and at Week 4, 8, 12, 16, 20 and 24 | 
| Sparse serum concentrations of testosterone |  | At pre-dose and at Week 4, 8, 12, 16, 20 and 24 |