Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

To identify the proportion of patients remaining medically castrated (testosterone level < 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Triptorelin Pamoate

Criteria

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