metastatic castration-resistant prostate carcinoma
Conditions
Sponsors
Otto-von-Guericke-Universität Magdeburg
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the impact of the AR-V7-status and the number of circulating tumor cells (CTCs) to the baseline assessment on the radiologic progression free survival (rPFS) in patients with mCRPC under first line therapy with Zytiga®.;Secondary Objective: 1. Assessment of the frequency of circulating tumor cells (CTC) in patients with mCRPC under first line therapy with Zytiga® 2. AR-V7- conversion rate under first line therapy with Zytiga® 3. OS with mCRPC under first line therapy with Zytiga® 4. Correlation of PSA, CTCs and AR-V7-status with rPFS and OS under first line therapy with Zytiga® 5. Prognostic value of CTCs and AR-V7-status to the week 12 visit for rPFS and OS 6. Assessment of the life quality of the patients;Primary end point(s): Radiologic progression-free survival under tehrapy with Zytiga® as first lien therapy with consideration of the AR-V7-status and the number of CTCs.;Timepoint(s) of evaluation of this end point: Baseline, Week 12 ± 1 Week and at progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 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 3. PSA development under first line therapy with Zytiga® 4. OS under first line therapy with Zytiga® 5. Life Quality: - pain scale: VAS/NRS - FACT-P, Functional Assessment of Cancer Therapy-Prostate - QLQ-C30 - EORTC Quality of Life Questionnaire-Cancer 6. Documentation of toxicities;Timepoint(s) of evaluation of this end point: Baseline, Week 12 ± 1 Week and at progression | — |
Countries
Germany
Contacts
Public ContactProf. Dr. Martin Schostak
Universitätsklinik für Urologie
Outcome results
None listed