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®)

Recruitment & Eligibility

Status: Recruiting stopped after recruiting started

Sex: Male

Target Recruitment: 23

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiologic progression-free survival under therapy with Zytiga® as first line therapy with consideration of the AR-V7-status and the number of CTCs.

Secondary Outcome Measures

Name	Time	Method
1. Number of CTCs at three time points: baseline prior to therapy start with Zytiga®, after 12 weeks ± 1 week therapy with Zytiga® and at radiologic progression <br>2. AR-V7-status at three time points: baseline prior to therapy start with Zytiga®, after 12 weeks ± 1 week therapy with Zytiga® and at radiologic progression <br>3. PSA development under first line therapy with Zytiga®<br>4. OS under first line therapy with Zytiga®<br>5. Life Quality:<br>- pain scale: VAS/NRS<br>- FACT-P, Functional Assessment of Cancer Therapy-Prostate<br>- QLQ-C30<br>- EORTC Quality of Life Questionnaire-Cancer<br>6. Documentation of toxicities

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