GP Extended Action Triptorelin

• Status: Terminated
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to demonstrate that treatment with a 6-monthly injection of hormone therapy is as good and as well tolerated as the standard 3-monthly hormone therapy injections available for treating prostate cancer. The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Goserelin; Leuprolide; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• Patients must give written (personally signed and dated) informed consent before completing any study related procedure.

• Patients must be 18 years old or over.

• Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment

• Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL

• Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests

• Patients must be stable on a 3-monthly LHRH agonist injection with stable PSA levels between screening and baseline (i.e. the baseline value must either be lower or less than 25% higher than the Screening value or if ≥25% higher, ≤0.5ng/mL higher than the screening value).

In addition:

• For patients with locally advanced prostate cancer (M0), LHRH agonist injection (any formulation) must have been initiated within the last 3 years from Baseline,

• For patients with metastatic prostate cancer (M+) and a Gleason score

≤ 7, LHRH agonist injection (any formulation) must have been initiated within the last 2 years from Baseline,

• For patients with metastatic prostate cancer (M+) and a Gleason score > 7, LHRH agonist injection (any formulation) must have been initiated within the last 12 months from Baseline.

• Patients must have an estimated life expectancy of at least twelve months according to the investigator's assessment.

Exclusion Criteria:

• Patients have had previous surgical castration or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).

• Patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions.

• Patients have received investigational drug(s) or treatment(s) within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).

• Patients have had a diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metastatic basal cell carcinoma.

• Patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy.

• Patients scheduled to receive palliative radiotherapy during the course of the study.

• Patients receiving an LHRH agonist as neo-adjuvant to radiotherapy or adjuvant to radiotherapy.

• Patients receiving LHRH agonist as adjuvant to surgery.

• Patients scheduled to undergo radical prostatectomy during the course of the study.

• Patients with known hypersensitivity to LHRH agonists, their analogues or any or any other component of the products to be administered.