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

Ipsen

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01257425

A-94-52014-178

2010-019632-12 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

109 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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