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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85days] for serum testosterone in patients with advanced prostate cancer.

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Martin Gerwe, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

A-94-52014-178

NCT ID:

NCT01257425

Start Date:

December 2010

Completion Date:

May 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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