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

Ipsen

Status and phase

Terminated

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Triptorelin (Decapeptyl®) - Treatment 8 months (pivotal study) followed by a treatment extension of 8 months (extension study)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00415246

2006-001511-30 (EudraCT Number)

2-55-52014-145

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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