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

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Triptorelin embonate 22.5 mg

• Registration Number: NCT01656161
• Lead Sponsor: Debiopharm International SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-31
• Study First Submitted QC: 2012-07-31
• Study First Posted: 2012-08-02
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-08
• Results First Submitted: 2015-08-13
• Results First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Results First Posted: 2015-09-15
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triptorelin embonate 22.5 mg	Triptorelin embonate 22.5 mg	Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)	within 337 days

Secondary Outcome Measures

Name	Time	Method
Testosterone PD Metrics for First Injection: Time to Castration (Tcast)	Days 1-169
Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)	Days 1-169
Triptorelin PK Metrics for Both Injections: Cmax	Days 1-169 and Days 169-337
Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337	Baseline through Day 337
Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)	Days 1-169
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
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: Concentration 0 Hour	Days 1-169 and Days 169-337
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
Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)	Days 1-169

Trial Locations

Locations (10)

East Rand Urology Research Unit, Clinix Private Clinic; 🇿🇦 Johannesburg, Gautang, South Africa

Paarl Medical Centre; 🇿🇦 Paarl, Cape Town, Western Cape, South Africa

Department of Urology, Tygerberg Hospital; 🇿🇦 Tygerberg, Cape Town, South Africa

Vergelegen Medi-Clinic; 🇿🇦 Somerset West, Cape Town, South Africa

JCM Bahlmann; 🇿🇦 George, Eastern Cape, South Africa

Clinresco Centres (Pty) Ltd; 🇿🇦 Kempton Park, Gauteng, South Africa

Clinical Trial Unit, Room 2-54, Prinshof Medical Campus; 🇿🇦 Pretoria, Gauteng, South Africa

Pretoria Urology Hospital; 🇿🇦 Pretoria, Gauteng, South Africa

Wilmed Park Hospital; 🇿🇦 Klerksdorp, North West Province, South Africa

New Groote Schuur Hospital, Division of Urology; 🇿🇦 Cape Town, South Africa