NL-OMON40179已完成4 期
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 - EFFECT
Astellas Pharma B.V.0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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
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