Clinical trial NCT01656161: Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Debiopharm International SA
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2012-08-02
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
timeFrame: within 337 days
Secondary outcomes:
measure: 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
timeFrame: on Days 1 and 169
measure: Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337
timeFrame: Baseline through Day 337
measure: 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)
timeFrame: Day 171
measure: Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC)
timeFrame: Days 1-169
measure: Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax)
timeFrame: Days 1-169
measure: Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax)
timeFrame: Days 1-169
measure: Testosterone PD Metrics for First Injection: Time to Castration (Tcast)
timeFrame: Days 1-169
measure: Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC)
timeFrame: Days 1-169 and Days 169-337
measure: Triptorelin PK Metrics for Both Injections: Cmax
timeFrame: Days 1-169 and Days 169-337
measure: Triptorelin PK Metrics for Both Injections: Concentration 0 Hour
timeFrame: Days 1-169 and Days 169-337
Other outcomes:
Locations:
city: Paarl
country: South Africa
facility: Paarl Medical Centre
state: Cape Town, Western Cape
city: Somerset West
country: South Africa
facility: Vergelegen Medi-Clinic
state: Cape Town
city: Tygerberg
country: South Africa
facility: Department of Urology, Tygerberg Hospital
state: Cape Town
city: George
country: South Africa
facility: JCM Bahlmann
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: East Rand Urology Research Unit, Clinix Private Clinic
state: Gautang
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd
state: Gauteng
city: Pretoria
country: South Africa
facility: Clinical Trial Unit, Room 2-54, Prinshof Medical Campus
state: Gauteng
city: Pretoria
country: South Africa
facility: Pretoria Urology Hospital
state: Gauteng
city: Klerksdorp
country: South Africa
facility: Wilmed Park Hospital
state: North West Province
city: Cape Town
country: South Africa
facility: New Groote Schuur Hospital, Division of Urology
Study officials:
affiliation: Debiopharm SA
name: Eija Lundstrom, MD
role: STUDY_DIRECTOR
affiliation: Private Practitioner
name: J. Bahlmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German.
citation: Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10.