EUCTR2005-004094-25-CZ进行中（未招募）不适用
A phase IIIb randomized study of intermittent versus continuous androgen deprivation therapy using ELIGARD 22.5 mg 3-month depot in subjects with relapsing or locally advanced prostate cancer who are responsive to such therapy - ICELAND Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
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
- •At study entry (visit 1):
- •1. Written informed consent has been obtained
- •2. Male subjects aged >= 18 and <80 years old
- •3. Histologically or cytologically confirmed adenocarcinoma of the prostate meeting the following criteria:
- •- Locally advanced (stage T3 or T4) prostate cancer, N0 or N+, M0 with PSA >= 5 ng/ml, or
- •- Relapsing prostate cancer following radical prostatectomy for clinically localized PCa with a serum PSA of >= 0.4 ng/ml that has risen on three successive occasions (values drawn at least 2 weeks apart) as compared to a previous reference value or,
- •- Relapsing prostate cancer following radiotherapy with a serum PSA of >= 1 ng/ml that has risen on three successive occasions (values drawn at least 2 weeks apart) as compared to a previous reference value.
- •4. Gleason score of >= 6
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •6. Life expectancy of at least 5 years
- •At randomization (visit 4):
- •7. Two successive decreasing serum PSA levels =< 1 ng/ml (at least 2 weeks apart) following 6 months of complete androgen suppression
- •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
排除标准
- •At study entry (visit 1):
- •1. Any suspected second primary tumors, including evidence from special stains (e.g. Prostatic acid phosphatase)
- •2. Evidence of metastatic disease on bone scintigraphy or CT scan (bone scintigraphy or CT scan from within 6 months of V1 is acceptable)
- •3. Other malignancy within the last 5 years except;
- •- Adequately treated basal cell or squamous cell skin cancer
- •- Adequately treated other superficial cancer
- •4. Subjects with acute spinal cord compression, uni- or bilateral ureteric obstruction
- •5. Any concurrent biological response modifier therapy
- •6. Concurrent chemotherapy
- •7. Less than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of more than 4 months (single or combination therapy is allowed)
- •8. Less than 6 months since prior 5-alpha reductase inhibitor treatment for prostate cancer and BPH.
- •9. Other concurrent hormonal therapy (progesterone preparations for the treatment of subjects presenting with hot flushes are permitted)
- •10. Any concurrent radiotherapy
- •11. Testosterone at baseline =< 1.7 nmol/L or 50 ng/dL
- •12. Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine >150 micro mol/L, AST or ALT > 2x upper limit of normal range (ULN), g-GT > 3x ULN and/or abnormal clinically significant serum total bilirubin (as assessed at visit 1 lab sampling)
- •13. Subjects with hypersensitivity to GnRH or other GnRH analogues or leuprorelin acetate or any of the excipients of ELIGARD 22.5 mg
- •14. Subjects with hypersensitivity to CASODEX 50 mg or any of the excipients.
- •15. Any clinical condition, which in the opinion of the investigator would not allow safe completion of the study.
- •16. Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study.
研究者
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