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The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCVAC/PCa Arm | Experimental | Dendritic Cells DCVAC/PCA Experimental therapy |
|
| Standard Therapy | No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cells DCVAC/PCa | Biological | DCVAC/PCa Experimental therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40 | 40 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization | 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 |
|---|---|---|---|---|---|---|
| Brno | Czechia | |||||
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| Proportion of Patients with Objective disease progression within 2 years | 104 Weeks |
| Number of Patients requiring further therapy at 2 years | 104 Weeks |
| Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization | 104 Weeks |
| Proportion of patients after RPE with biochemical relapse within 2 years of randomization | 104 Weeks |
| Proportion of patients with progressive increase in PSA within 2 years of randomization | 104 Weeks |
| Overall survival | 104 Weeks |
| Hradec Králové |
| Czechia |
| Jablonec nad Nisou | Czechia |
| Jihlava | Czechia |
| Mníšek pod Brdy | Czechia |
| Nový Jičín | Czechia |
| Olomouc | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Uherské Hradiště | Czechia |
| Ústí nad Labem | Czechia |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| 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 |
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