Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg (PAMIS)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- Kreiskrankenhaus, Abteilung Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Loretto Krankenhaus, Abteilung Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
- Urologische Klinik
- Praxis für Urologie
- Praxis für Urologie
- Praxis für Urologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01257425
Brief Title
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
Acronym
PAMIS
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
Arm Type
Other
Arm Title
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
Description
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 Outcome Measure Information:
Title
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)
Description
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
Title
Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)
Description
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
Title
Maximum Concentration of Serum Testosterone [Cmax] - Raw Data
Description
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
Title
Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data
Description
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
Title
Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL
Description
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 Frame
12 weeks
Title
Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Kreiskrankenhaus, Abteilung Urologie
City
Bad Bergzabern
ZIP/Postal Code
76887
Country
Germany
Facility Name
Praxis für Urologie
City
Bad Ems
Country
Germany
Facility Name
Praxis für Urologie
City
Bamberg
ZIP/Postal Code
96047
Country
Germany
Facility Name
Praxis für Urologie
City
Berlin
Country
Germany
Facility Name
Praxis für Urologie
City
Braunschweig
Country
Germany
Facility Name
Praxis für Urologie
City
Cham
Country
Germany
Facility Name
Praxis für Urologie
City
Chemnitz
Country
Germany
Facility Name
Praxis für Urologie
City
Dessau
Country
Germany
Facility Name
Loretto Krankenhaus, Abteilung Urologie
City
Freiburg
ZIP/Postal Code
79100
Country
Germany
Facility Name
Praxis für Urologie
City
Gelsenkirchen
Country
Germany
Facility Name
Praxis für Urologie
City
Herzberg
Country
Germany
Facility Name
Praxis für Urologie
City
Lutherstadt Eisleben
Country
Germany
Facility Name
Praxis für Urologie
City
Marburg
Country
Germany
Facility Name
Praxis für Urologie
City
Markkleeberg
Country
Germany
Facility Name
Praxis für Urologie
City
Miltenberg
Country
Germany
Facility Name
Praxis für Urologie
City
Mülheim
Country
Germany
Facility Name
Praxis für Urologie
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Praxis für Urologie
City
Neunkirchen
Country
Germany
Facility Name
Urologische Klinik
City
Neunkirchen
Country
Germany
Facility Name
Praxis für Urologie
City
Reutlingen
ZIP/Postal Code
72764
Country
Germany
Facility Name
Praxis für Urologie
City
Wesel
Country
Germany
Facility Name
Praxis für Urologie
City
Wuppertal
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
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