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®)

Phase 1

• Conditions: metastatic castration-resistant prostate carcinoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002735-16-DE
• Lead Sponsor: Otto-von-Guericke-Universität Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-04
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 340

Inclusion Criteria

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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified