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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

• Registration Number: NCT01257425
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-08
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Primary Completion: 2012-02
• Study Completion: 2012-05
• Results First Submitted: 2013-09-27
• Results First Submitted QC: 2014-04-30
• Results First Posted: 2014-05-26
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.	Triptorelin Pamoate (Pamorelin® LA 11.25 mg)	-
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.	Triptorelin Pamoate (Pamorelin® LA 11.25 mg)	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).	1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose	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.

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration of Serum Testosterone [Cmax] - Raw Data	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose	Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL	12 weeks	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.
Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL	12 weeks	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.
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose	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.
Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)	85, 87, 113, 141 and 169 days post-dose	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.
Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data	1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose	Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.

Trial Locations

Locations (4)

Urologische Klinik; 🇩🇪 Neunkirchen, Germany

Praxis für Urologie; 🇩🇪 Wuppertal, Germany

Kreiskrankenhaus, Abteilung Urologie; 🇩🇪 Bad Bergzabern, Germany

Loretto Krankenhaus, Abteilung Urologie; 🇩🇪 Freiburg, Germany