EUCTR2012-000101-69-NL进行中（未招募）不适用
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 study
Astellas Pharma Europe Ltd. (APEL)0 个研究点开始时间: 2013年7月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •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
排除标准
- •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 (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
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