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

Medizinische Fakultät0 个研究点目标入组 23 人开始时间: 2017年3月13日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Signed informed consent
•2. Age = 18 years
•3. Patients with metastasic castration-resistant prostate carcinoma (mCRPC), = 3 months, for who a therapeutic decision is to be taken
•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
•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/r visceral organs) as per imaging (CT and/or MRT and/or bone scintigraphy 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

•1. Brain metastases
•2. Severe liver impairment (ALT und AST >50% ULN); child Pugh class C
•3. Severe neurological diseases
•4. Previous therapy with androgen receptor targeted substances like Abirateron and Enzalutamid
•5. A previous therapy in the primary, castration-naïve status with up to 6 cycles Docetaxel (see DGU guideline 2017) is allowed, a previous therapy with Docetaxel in castration-resistant status is not allowed
•6. Hypersensitivity against the active compound or one of the other components listed in section 6.1 of the expert Information of Zytiga®
•7. Participation in another clinical trial in the last 4 weeks

发起方

Medizinische Fakultät