Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized Prostate Cancer.

Detailed Description
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Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Official Title
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Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Localized High-risk Prostate Cancer After Primary Radiotherapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: Dendritic Cells DCVAC/PCa
* Radiation: Standard radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18 years and older Histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml Indication for prostate cancer radical radiotherapy Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: Primary surgical treatment of prostate cancer Prior or ongoing chemotherapy for prostate cancer Participation in other clinical study or administration of other evaluated drug within 30 day prior screening Unresolved lasting obstruction of urinary system Other uncontrolled inter-current illness Treatment with immunotherapy against Prostate Cancer Clinically significant cardiovascular disease History of primary immunodeficiency Active autoimmune disease requiring treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCVAC/PCa arm post radiotherapy<br>Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy | Biological: Dendritic Cells DCVAC/PCa<br>* DCVAC/PCa arm post radiotherapy<br>|
| Active Comparator: Standard radiotherapy<br>Standard care | Biological: Dendritic Cells DCVAC/PCa<br>* DCVAC/PCa arm post radiotherapy<br>Radiation: Standard radiotherapy<br>* radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Prostate Specific Antigen (PSA) failures in 5 years | PSA failure per Phoenix criteria of increase of 2ng/mL over nadir | Enrollment up to 260 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients without use of salvage therapy within 5 years | Calculation of the proportion of patients without use of salvage therapy within 5 years | Enrollment up to 260 weeks | 
| Frequency of Adverse Events | Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events | enrollment up to 260 weeks | 
| Proportion of Patients without Objective disease progression within 5 years | Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy | Enrollment up to 260 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, Prostate Cancer, Biological, Vaccine