GP Extended Action Triptorelin

A Phase IV, Randomised, Open-label, Multi-centre Study to Assess the Impact on Disease Control, Safety, Patient and Clinician Experience of Changing Patients With Advanced Prostate Cancer From a 3-monthly LHRH Agonist to 6-monthly Injections of Decapeptyl® SR 22.5 MG

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.

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.