An exploratory, open label, single-arm study to evaluate the effect of Eligard® 6-month on biomarkers of disease in patients with metastatic prostate cancer

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Subject is eligible for the study if all the following apply:
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 [LoD] for the central lab assay, i.e. >= 10 copies per Polymerase Chain Reaction, PCR).
9. Patient has given written informed consent.

Exclusion Criteria

Subject will be excluded from participation if any of the following apply:
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 < 1,500/µL, platelet count < 100,000/µL, and hemoglobin < 5.6 mmol/L (9 g/dL) at screening.
13. Total bilirubin > 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.
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 agonists 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 o

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes from baseline of the following biomarkers variables:<br /><br><br /><br>• Testosterone levels in serum<br /><br>• PSA level in serum<br /><br>• PCA3 score in urine<br /><br>• Number of PSA mRNA copies in blood/PBMC<br /><br>• Number of PCA3 mRNA copies in blood/PBMC<br /><br>• Number of TMPRSS2-ERG mRNA copies in blood/PBMC<br /><br><br /><br>Safety: Reported treatment-emergent adverse events, including the grading<br /><br>according to the Common Terminology Criteria for Adverse Events (CTCAE),<br /><br>version 4.0.3).</p><br>

Secondary Outcome Measures