EUCTR2016-002735-16-DE进行中（未招募）1 期
Correlation between common clinical outcome parameters, CTC-changes and ARV7-status (androgen receptor splice variant 7) in patients with mCRPC treated with first line abiraterone acetat (Zytiga®) - STAR-V7
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
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. Signed informed consent
- •2. Age = 18 years
- •3. Patients with metastasic castration-resistant prostate carcinoma (mCRPC) = 3 months, for whom a therapy decision is due
- •4. = 5 Bone metastases in bone scintigraphy and/or visceral metastases in CT and/or MRT and/or PSMA-PET/CT (= 8 weeks) and/or patients with only non-regional lymph node metastases (outside the small pelvis), if at least 5 metastases with an extent of 5 cm each or extensive lymph node conglomerates are present here
- •5. No or mild pain symptoms
- •6. ECOG 0-1
- •7. Tumor progression under hormone therapy with LHRH-agonists/antagonists or maximum androgen blockade (MAB), respectively
- •8. Tumor progression: three times PSA increase (after stopping antiandrogens with previous MAB and no therapy with bicalutamide and flutamide in the last 4-6 weeks, time between measurements one week each, at least 25% increase of PSA, Basic value > 1ng/ml) and/or increase of metastases (in lymph nodes and/or bones and/or visceral organs) in the images (CT and/or MRT and/or bone scan and/or PSMA-PET/CT)referred to the last documented time
- •9. Testosteron in the castration area (= 0.2 ng/ml)
- •10. Palliative radiation and/or bone surgery must be at least 4 weeks ago
- •11. Minimal baseline CTC value = 2
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Brain metastases
- •2. Severe liver impairment (ALT und AST >50% ULN); child Pugh class C
- •3. Severe neurological diseases
- •4. Previous therapy with androgenreceptor-targeted substances like Abirateron and Enzalutamid,
- •5. Hypersensitivity against the active compound or one of the other components listed in section 6.1 of the expert Information of Zytiga®
- •6. Participation in another clinical trial in the last 4 weeks
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