Locally advanced or metastatic prostate cancer MedDRA version: 8.1 Level: PT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: triptorelin microimplant
Product Code: 52014
Pharmaceutical Form: Implant
INN or Proposed INN: TRIPTORELIN
CAS Number: 57773634
Current Sponsor code: 52014
Concentration unit: mg milligr
Sponsors
Beaufour Ipsen Pharma
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: To determine the proportion of patients remaining medically castrated (serum testosterone level < 50 ng/dL) at Day 240 following two SC administrations of a 4-month sustained-release (SR) formulation of Triptorelin. ;Secondary Objective: To determine the proportion of patients remaining medically castrated at Day 120 following 1 SC administration of the 4-month SR formulation To determine the proportion of patients castrated with a testosterone serum level <20 ng/dL on Day 120 and Day 240, after receiving 1 and 2 SC administrations of the 4-month SR formulation To determine the PD profile by measuring testosterone and LH serum levels. To evaluate the clinical and biological efficacy of the 4-month SR formulation (bone pain, urinary symptoms, PSA levels). To assess the clinical (local/systemic) and biological tolerance of the 4-month SR formulation To determine the PK profile of the 4-month SR formulation in a subset of 24 patients. To assess the accumulation of triptorelin after repeated injections in patients from sites having appropriate facilities. To document the testosterone flare in the subgroup of 24 PK patients following the 1st and 2nd administration of the 4-month SR formulation;Primary end point(s): To determibe the proportion of patients remaining medically castrated (testosterone serum level < 50 ng/dL) on Day 240 after receiving two subcutaneous administrations of the 4-month sustained-release (SR) formulation of Triptorelin. [Breakthrough is defined in a patient who achieved castration (testosterone serum level< 50ng/dL) as a single testosterone serum value above 50ng/dL not confirmed by a second measurement taken 1 week apart. These patients will stay on study] | — |
Countries
Belgium, France, Latvia, Lithuania, Portugal, United Kingdom
Outcome results
None listed