Patients with metastatic prostate cancer whom androgen deprivation therapy (ADT) is indicated MedDRA version: 17.0 Level: LLT Classification code 10007113 Term: Cancer of prostate System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Eligard 45 mg
Pharmaceutical Form:
Sponsors
Astellas Pharma Europe Ltd. (APEL)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male aged 18 years or older. 2. Confirmed metastatic prostate cancer for whom androgen deprivation therapy (ADT) is indicated. 3. Non-castrate level of serum testosterone (= 8 nmol/L (i.e.230 ng/dL)) at screening. 4. Serum PSA = 5 ng/mL at screening. 5. Eastern Cooperative Oncology Group (ECOG) score of 0-2 6. A life expectancy of at least 12 months. 7. Is able to tolerate injections of study drug and comply with the study requirements. 8. Positive blood PSA mRNA at screening. A positive PSA mRNA in PBMCs (defined as exceeding the Limit of Detection for the central lab assay, i.e. = 10 copies per PCR). 9. Patient has given written informed consent 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. History of bilateral orchidectomy. 2. History of any hormonal treatment/therapy with GnRH agonist, GnRH anti-agonist within 6 months of enrolment. 3. Treatment with anti-androgens (except where used to prevent testosterone flare up, starting up to 2 weeks prior to Eligard injection, according to local treatment guidelines), 5-a reductase inhibitors, estrogens and/or other any investigational hormone-derivative within 3 months of enrolment or 5-times the half-life, whichever is longer. 4. Any previous treatment with chemotherapy treatment for prostate cancer prior to the screening visit or within 6 months prior to screening for any other cancer. 5. Patients previously treated for cancer with hormonal therapy in whom treatment was stopped due to lack of efficacy, progression of the disease or lack of tolerability. 6. Previous treatments for cancer (including prostate cancer) within 6 months prior to enrolment: immunotherapy, external beam radiotherapy, brachytherapy, thermotherapy, or biological response modifiers (e.g. cytokines). 7. Known or suspected spinal cord compression or evidence of spinal metastases with risk of spinal compression, 8. Uni- or bilateral uretric obstruction. 9. Requiring concomitant use of anti-androgens during the course of the study (except where used to prevent testosterone flare up, starting up to 2 weeks prior to Eligard injection and continuing for up to 3 weeks, according to local treatment guidelines). 10. Previous or concomitant malignancies at other sites except effectively treated non-melanoma skin cancer or an effectively treated malignancy that has been in remission for at least 5 years. 11. Major surgery within 2 months prior to enrolment. 12. Absolute neutrophil count 1.5 times the upper limit of normal (ULN) at screening. This will not apply to subjects with Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology), who will be allowed in consultation with the sponsor. 14. Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times ULN at screening. 15. Creatinine > 177 µmol/L (2 mg/dL) at screening. 16. Albumin = 30 g/L (3.0 g/dL) at screening. 17. Any clinical condition, diagnosis, symptomatology or ongoing investigation, which, in the opinion of the Investigator, contraindicates their participation in this study. 18. Participation in any clinical study within = 1 month prior to screening (or 5 half lives of the drugs under investigation, whichever is greater). 19. Not available for follow-up assessments or unable to comply with study requirements. 20. Known or suspected hypersensitivity to leuprorelin acetate, to other GnRH agonist or to any of the excipients of Eligard. 21. Male subjects who are intending to donate sperm within 9 months following the injection of Eligard 22. Male subjects and their female spouses/partners who are of childbearing potential and are NOT using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continuing for 9 months from the time of the Eligard injection. Acceptable forms include: i. Established use of oral, injected or implanted hormonal methods of contraception. ii. Placement of an intrauterine device (IUD) or intra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of Eligard® on the following prostate cancer biomarkers: • Testosterone in serum • Prostate Specific Antigen (PSA) in serum • Prostate Cancer Antigen (PCA3) in urine • PSA mRNA in blood/PBMC • PCA3 mRNA in blood/PBMC • TMPRSS2-ERG mRNA in blood/PBMC A blood sample for RNA analysis will also be collected and stored for future investigation in patients who have given informed consent for these samples to be collected. ;Secondary Objective: Not applicable;Primary end point(s): Biomarker: Changes from baseline of the following biomarker variables: ? Testosterone levels in serum ? PSA level in serum ? PCA3 score in urine ? Number of PSA mRNA copies in blood/PBMC ? Number of PCA3 mRNA copies in blood/PBMC ? Number of TMPRSS2-ERG mRNA copies in blood/PBMC Safety: Reported treatment-emergent adverse events, including the grading according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.3). ;Timepoint(s) of evaluation of this end point: Up to 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactService Desk
Global Development Operations
Outcome results
None listed