EUCTR2012-005717-39-DE进行中（未招募）不适用
Randomized phase-II trial of abiraterone acetate plus LHRH-therapy versus abiraterone acetate sparing LHRH-therapy in patients with progressive chemotherapy-naïve castration-resistant prostate cancer (SPARE) - SPARE
niversität des Saarlandes0 个研究点开始时间: 2013年12月23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. Willing and able to provide written informed consent
- •2. Written Data Protection Consent has been obtained
- •3. Male aged 18 years and above
- •4. Histologically or cytologically confirmed adenocarcinoma of the prostate
- •5. Metastatic disease documented by positive bone scan or metastatic lesions other than liver or visceral metastasis on CT, MRI. If lymph node metastasis is
- •the only evidence of metastasis, it must be =2 cm in diameter
- •6. Prostate cancer progression documented by PSA according to PCWG2 or radiographic progression according to modified RECIST criteria
- •7. Asymptomatic or mildly symptomatic from prostate cancer. A score of 0-1 for the question of worst pain within last 24 hours (Appendix 8) will be considered
- •asymptomatic, and a score of 2-3 will be considered mildly symptomatic.
- •8. Medically castrated, with testosterone levels of <20-50 ng/dl (< 2.0 nM).
- •9. Previous anti-androgen therapy and progression after withdrawal. Patients who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment (=4 weeks since last flutamide, =6 weeks since last bicalutamide or nilutamide).
- •10. Eastern Cooperative Oncology Group (ECOG) Performance Status of =2
- •11. Hemoglobin =9.0 g/dL independent of transfusion
- •12. Platelet count =100,000 /µl
- •13. Serum albumin =3.0 g/dl
- •14. Serum creatinine < 1.5 x ULN or a calculated creatinine clearance =60 ml/min
- •15. Serum potassium =3.5 mmol/l
- •16. Liver function:
- •a. Serum bilirubin <1.5 x ULN (except for patients with documented Gilbert’s disease)
- •b. AST or ALT <2.5 x ULN
- •17. Able to swallow the study drug whole as a tablet
- •18. Life expectancy of at least 6 months
- •19. Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last study drug administration.
- •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 45
排除标准
- •1. Surgical castration (i.e. orchiectomy).
- •2. Application of any LHRH-therapy (LHRH-analogue or LHRH-antagonist) within 3 months (for patients receiving a 3-months formulation) or 1 months (for
- •patients receiving a 1-month formulation) prior to Cycle 1 day 1.
- •3. Patients receiving a 6- or 12-months formulation of LHRH-therapy
- •4. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
- •5. Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
- •6. Pathological finding consistent with small cell carcinoma of the prostate
- •7. Liver or visceral organ metastasis
- •8. Known brain metastasis
- •9. Use of opiate analgesics for cancer-related pain, including codeine, tramadol, tilidin and others (see Appendix 9), currently or anytime within 4 weeks of Cycle 1 Day 1.
- •10. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
- •11. Radiation therapy for treatment of the primary tumour within 6 weeks of Cycle 1, Day 1
- •12. Radiation or radionuclide therapy for treatment of metastatic CRPC
- •13. Prior treatment with Abiraterone acetate or other CYP17 inhibitors (ketoconazole, TAK700, TOK001) or investigational agents targeting the androgen receptor for prostate cancer for more than 7 days
- •14. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole)
- •within 4 weeks of Cycle 1, Day 1
- •15. Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
- •16. Bicalutamide (Casodex), nilutamide (andron) within 6 weeks of Cycle 1 Day 1 (patients whose PSA did not decline for three or more months in response to antiandrogen given as a second line or later intervention will require only a two week washout prior to Cycle 1, Day 1)
- •17. Uncontrolled hypertension (systolic BP =160 mmHg or diastolic BP =95 mmHg). Patients with a history of hypertension are allowed provided that blood
- •pressure is controlled by anti-hypertensive treatment
- •18. Active or symptomatic viral hepatitis or chronic liver disease
- •19. History of pituitary or adrenal dysfunction
- •20. Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or
- •New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of <50 % at baseline
- •21. Any condition that requires treatment with Digoxin, digitoxin, and other digitalis drugs
- •22. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy
- •23. Other malignancy with a =30 % probability of recurrence within 24 months, except non-melanoma skin cancer.
- •24. Administration of an investigational therapy within 30 days of Cycle 1, Day 1
- •25. Any condition, which, in the opinion of the investigator, would preclude participation in this trial.
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