Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg (PAMIS)

A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer

The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85day] for serum testosterone in patients with advanced prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Bad Bergzabern, Germany, 76887
    • Kreiskrankenhaus, Abteilung Urologie
  • Bad Ems, Germany
    • Praxis für Urologie
  • Bamberg, Germany, 96047
    • Praxis für Urologie
  • Berlin, Germany
    • Praxis für Urologie
  • Braunschweig, Germany
    • Praxis für Urologie
  • Cham, Germany
    • Praxis für Urologie
  • Chemnitz, Germany
    • Praxis für Urologie
  • Dessau, Germany
    • Praxis für Urologie
  • Freiburg, Germany, 79100
    • Loretto Krankenhaus, Abteilung Urologie
  • Gelsenkirchen, Germany
    • Praxis für Urologie
  • Herzberg, Germany
    • Praxis für Urologie
  • Lutherstadt Eisleben, Germany
    • Praxis für Urologie
  • Marburg, Germany
    • Praxis für Urologie
  • Markkleeberg, Germany
    • Praxis für Urologie
  • Miltenberg, Germany
    • Praxis für Urologie
  • Mülheim, Germany
    • Praxis für Urologie
  • München, Germany, 81241
    • Praxis für Urologie
  • Neunkirchen, Germany
    • Praxis für Urologie
  • Neunkirchen, Germany
    • Urologische Klinik
  • Reutlingen, Germany, 72764
    • Praxis für Urologie
  • Wesel, Germany
    • Praxis für Urologie
  • Wuppertal, Germany
    • Praxis für Urologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
• Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
• Karnofsky performance index > 70
• Expected survival ≥ 9 months

Exclusion Criteria:

• Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
• Any current use or 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 progesterone
• Patient at risk of spinal cord compression or ureter obstruction
• Prior hypophysectomy or adrenalectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.	Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg); Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.
Other: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.	Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg); Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).	Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.	1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)	Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)	Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.	85, 87, 113, 141 and 169 days post-dose
Maximum Concentration of Serum Testosterone [Cmax] - Raw Data	Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data	Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL	tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.	12 weeks
Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL	tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time. Analysis of tcast was based on the Kaplan-Meier estimator.	12 weeks

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: A-94-52014-178; 2010-019632-12 (EudraCT Number)