NCT01257425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2 prostate-cancer

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 26, 2014

Completed
Last Updated

February 8, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

December 8, 2010

Results QC Date

September 27, 2013

Last Update Submit

January 24, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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 of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)

    85, 87, 113, 141 and 169 days post-dose

  • 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

  • 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

  • Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.

OTHER
Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.

OTHER
Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

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.

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Kreiskrankenhaus, Abteilung Urologie

Bad Bergzaben, 76887, Germany

Location

Praxis für Urologie

Bad Ems, Germany

Location

Praxis für Urologie

Bamberg, 96047, Germany

Location

Praxis für Urologie

Berlin, Germany

Location

Praxis für Urologie

Braunschweig, Germany

Location

Praxis für Urologie

Cham, Germany

Location

Praxis für Urologie

Chemnitz, Germany

Location

Praxis für Urologie

Dessau, Germany

Location

Praxis für Urologie

Eisleben Lutherstadt, Germany

Location

Loretto Krankenhaus, Abteilung Urologie

Freiburg im Breisgau, 79100, Germany

Location

Praxis für Urologie

Gelsenkirchen, Germany

Location

Praxis für Urologie

Herzberg, Germany

Location

Praxis für Urologie

Marburg, Germany

Location

Praxis für Urologie

Markkleeberg, Germany

Location

Praxis für Urologie

Miltenberg, Germany

Location

Praxis für Urologie

Mülheim, Germany

Location

Praxis für Urologie

München, 81241, Germany

Location

Praxis für Urologie

Neunkirchen, Germany

Location

Urologische Klinik

Neunkirchen, Germany

Location

Praxis für Urologie

Reutlingen, 72764, Germany

Location

Praxis für Urologie

Wesel, Germany

Location

Praxis für Urologie

Wuppertal, Germany

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Results Point of Contact

Title
Director, Uro-oncology
Organization
Ipsen
clinical.trials@ipsen.com
clinical.trials@ipsen.com

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 9, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2012

Study Completion

May 1, 2012

Last Updated

February 8, 2019

Results First Posted

May 26, 2014

Record last verified: 2019-01

Locations

DE(22)