Locally advanced or metastatic prostate cancer MedDRA version: 12.0 Level: PT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Product Name: Triptorelin 6-month
Product Code: 52014
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Triptore
Sponsors
Ipsen Pharma SAS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To model the PCA3 score change at 6 months post-treatment using a multivariate linear model and the following variables outcomes at baseline: age, Prostate Specific Antigen (PSA), clinical stage (TNM), pathological grade (Gleason score) and T2-ERG score.; Secondary Objective: •To model the PCA3 score change at 1-month and 3-month post-treatment using a similar model as described above. •To assess the 6-month post-treatment time profile of PCA3 score changes. •To perform a descriptive analysis of T2-ERG (at baseline, 1-month, 3-month and 6-month post-treatment). •To assess the 6-month post-treatment time profile of T2-ERG score changes. •To assess the clinical efficacy and safety of triptorelin 22.5mg over a 6-month treatment period. ;Primary end point(s): PCA3 score expressed as a ratio of PCA3 mRNA over PSA mRNA at 6-month post-treatment. | — |
Countries
Belgium, France, Italy, Latvia, Lithuania, Netherlands, Spain, United Kingdom
Outcome results
None listed