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A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-Release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

A Phase III, Single Arm, Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-Release Formulation of Triptorelin, a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer


Inclusion Criteria:



- Patient must give written (personally signed and dated) informed consent before
completing any study-related procedure, which means any assessment or evaluation that
would not have formed part of the normal medical care of the patient

- Patient must be 18 years old or over

- Patient must have a histologically-confirmed diagnosis of locally advanced or
metastatic prostate cancer or presenting a relapse after curative treatment which is
amenable to androgen deprivation therapy

- Patient must have an estimated survival time of greater than 8 months according to
the investigator's assessment

Exclusion Criteria:

- Patient at risk of a serious complication in the case of tumour flare (vertebral
metastases threatening spinal cord compression or with significant obstructive
uropathy)

- Patient who underwent a previous surgical castration

- Prostate cancer therapy within 2 months of baseline visit

- Patient with testosterone level below 150 ng/dL at screening

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL.

Outcome Time Frame:

Day 240

Principal Investigator

Beata Maj, MD

Investigator Role:

Study Director

Investigator Affiliation:

Ipsen

Authority:

Belgium: Federal Agency for Medicines and Health Products, FAMHP

Study ID:

2-55-52014-145

NCT ID:

NCT00415246

Start Date:

November 2006

Completion Date:

October 2007

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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