A phase III, single arm, multicentre study to evaluate the efficacy and safety of a subcutaneous four-month sustained-release formulation of triptorelin, a gonadotrophin releasing hormone analogue in patients with prostate cancer - Not applicable

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 100

Inclusion Criteria

All subjects must fulfil the following:
1)Patient must give written (personally signed and dated) informed consent before completing any study-related procedure
2)Patient must be 18 years old or over,
3)Patient must have a histological-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy,
4)Patient must have an estimated survival time of greater than twelve months according to the investigator’s assessment,
5)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

Exclusion Criteria

Subjects will not be included in the study if:
1)Patient at risk of a serious complication in the case of tumour flare (vertebral metastases threatening spinal cord compression or with significant obstructive uropathy),
2)Patient who underwent a previous surgical castration,
3)Prostate cancer therapy (radiation/surgery) within 2 months of baseline,
4)Patient with serum testosterone level below 150 ng/dL at screening,
5)Hormone therapy (GnRH analogue, estrogens or steroid antiandrogens) within 3 months of baseline (previous treatment with non-steroid antiandrogens is permitted),
6)Any condition that may preclude subcutaneous injection,
7)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: severe medical conditions, hypercalcemia, brain metastasis, psychiatric disorders, active or uncontrolled infection, known pituitary disease,
8)Patient with abnormal hepatic/renal functions: creatinine and bilirubin > 1.5xUNL and/or ASAT/ALAT > 2.5xUNL, alkaline phosphatase > 2.5xUNL in the absence of liver and bone metastasis or > 5xULN in the presence of liver and bone metastasis,
9)Patient who has received any investigational drug or treatment within 30 days prior to study entry or will require a concurrent treatment with any other experimental drugs or treatments,
10)Diagnosis of any cancer without a history of stability/remission within 5 years of screening, with the exception of non-metatastic basal and/or squamous cell carcinoma of the skin,
11)Any significant concomitant medical disorder.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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