Clinical trial NCT01257425: Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 109
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
timeFrame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
Secondary outcomes:
measure: Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)
timeFrame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
measure: Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)
timeFrame: 85, 87, 113, 141 and 169 days post-dose
measure: Maximum Concentration of Serum Testosterone [Cmax] - Raw Data
timeFrame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
measure: Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data
timeFrame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
measure: Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL
timeFrame: 12 weeks
measure: Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bad Bergzabern
country: Germany
facility: Kreiskrankenhaus, Abteilung Urologie
city: Bad Ems
country: Germany
facility: Praxis für Urologie
city: Bamberg
country: Germany
facility: Praxis für Urologie
city: Berlin
country: Germany
facility: Praxis für Urologie
city: Braunschweig
country: Germany
facility: Praxis für Urologie
city: Cham
country: Germany
facility: Praxis für Urologie
city: Chemnitz
country: Germany
facility: Praxis für Urologie
city: Dessau
country: Germany
facility: Praxis für Urologie
city: Freiburg
country: Germany
facility: Loretto Krankenhaus, Abteilung Urologie
city: Gelsenkirchen
country: Germany
facility: Praxis für Urologie
city: Herzberg
country: Germany
facility: Praxis für Urologie
city: Lutherstadt Eisleben
country: Germany
facility: Praxis für Urologie
city: Marburg
country: Germany
facility: Praxis für Urologie
city: Markkleeberg
country: Germany
facility: Praxis für Urologie
city: Miltenberg
country: Germany
facility: Praxis für Urologie
city: Mülheim
country: Germany
facility: Praxis für Urologie
city: München
country: Germany
facility: Praxis für Urologie
city: Neunkirchen
country: Germany
facility: Praxis für Urologie
city: Neunkirchen
country: Germany
facility: Urologische Klinik
city: Reutlingen
country: Germany
facility: Praxis für Urologie
city: Wesel
country: Germany
facility: Praxis für Urologie
city: Wuppertal
country: Germany
facility: Praxis für Urologie
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: