PROSTATE CANCER ANTIGEN-3 (PCA-3) AND TMPRSS2-ERG (T2-ERG) SCORE CHANGES DURING INITIATION OF ANDROGEN DEPRIVATION THERAPY (ADT) WITH TRIPTORELIN 22.5MG IN PATIENTS WITH ADVANCED PROSTATE CANCER (PCA): A PHASE III, SINGLE ARM MULTICENTRE STUDY. - Triptocare

Ipsen Pharma SAS0 个研究点目标入组 325 人开始时间: 2009年9月11日最近更新: 2019年11月25日

试验速览

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•All patients must fulfil the following:
•Patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
•Patient must be 18 years old or over.
•Patient must have a histologically confirmed, locally advanced or metastatic prostate cancer, and be naïve to androgen deprivation therapy, and be candidate for hormonal treatment.
•Patient must have an estimated survival time of at least twelve months according to the investigator’s assessment.
•Patient must have a performance status score = 2 according to the WHO criteria.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients will not be included in the study if:
•The patient with risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or significant obstructive uropathy).
•The patient has had previous surgical castration.
•The patient has had previous or has planned curative prostate cancer therapy (radiation/surgery).
•The patients has had previous hormone therapy (GnRH analogues, estrogens or anti-androgens).
•The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or presents any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastasis, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
•Patient who have received investigational drug or treatment within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments.
•Diagnosis of any other cancer without a history of stability/remission within five years of screening, with the exception of non-metatastic basal and/or squamous cell carcinoma of the skin.
•Known hypersensitivity to triptorelin, GnRH, other GnRH agonist analogues or analogues to any excipients of the IMP.

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