gp extended action triptorelin

Conditions: Prostate Cancer

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.


Eligibility 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.