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

Ipsen109 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Prostate Cancer

Interventions

Triptorelin Pamoate (Pamorelin® LA 11.25 mg)DRUG

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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Kreiskrankenhaus, Abteilung Urologie

Bad Bergzaben, Germany

Praxis für Urologie

Bad Ems, Germany

Outcomes

Primary Outcomes

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.

Time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose

Data from ClinicalTrials.gov

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