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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004735-32 | EudraCT Number |
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The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCVAC/PCa add on to Standard of Care | Experimental | Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care |
|
| Standard of Care | Active Comparator | Docetaxel as an Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | DCVAC/PCa is the experimental therapy added on to Docetaxel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | 135 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Progression Free Survival | 135 weeks | |
| Duration to Prostate Specific Antigen (PSA) Progression | 135 weeks | |
| Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Scheiner, PhD | Sotio Biotech Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | Czechia | |||||
possibly shared on EMA website
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| Docetaxel | Drug | Docetaxel is Standard of Care First Line Chemotherapy |
|
|
| 0, 10, 22, 37, 53, 65 weeks |
| Changes in Pain assessed by EORTC QLQ-C30 | 0, 10, 22, 37, 53, 65 weeks |
| Incidence of Adverse Events | 135 weeks |
| Hradec Králové |
| Czechia |
| Jihlava | Czechia |
| Liberec | Czechia |
| Nová Ves pod Pleší | Czechia |
| Olomouc | Czechia |
| Ostrava | Czechia |
| Prague | Czechia |
| Ústí nad Labem | Czechia |
| Zlín | Czechia |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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