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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004986-34 | EudraCT Number |
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The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCVAC/PCA added Standard Hormone Therapy | Experimental | Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy |
|
| Standard of Care Hormone Therapy | Active Comparator | Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with PSA Progression | 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with Progression of Disease | 0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks | |
| Frequency of Adverse Events | 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Scheiner, PhD | Sotio-Accord | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jablonec nad Nisou | Czechia | |||||
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Leuprolide acetate | Drug | Standard of Care Hormone Therapy as an Active Comparator |
|
|
| Goserelin Acetate | Drug | Standard of Care Hormone Therapy as an Active Comparator |
|
|
| Frequency of Skeletal Related Events | 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks |
| Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30 | European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30 | 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks |
| Changes in Pain assessed by EORTC QLQ-C30 | Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30 | 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks |
| Jihlava |
| Czechia |
| Liberec | Czechia |
| Mníšek pod Brdy | Czechia |
| Olomouc | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Ústí nad Labem | Czechia |
| Zlín | Czechia |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |