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Completed

NCT Number: NCT01257425

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Kreiskrankenhaus, Abteilung Urologie, Bad Bergzaben, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).

    Time frame: 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 outcomes

  1. Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)

    Time frame: 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.

  2. Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)

    Time frame: 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.

  3. Maximum Concentration of Serum Testosterone [Cmax] - Raw Data

    Time frame: 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.

  4. Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data

    Time frame: 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.

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

    Time frame: 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.

  6. Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: PAMIS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 9, 2010
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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