Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With 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 doubling times for patients with localized Prostate Cancer.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: Dendritic Cells DCVAC/PCa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18 years and older Histologically confirmed pT2 prostate cancer Post radical prostatectomy PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: Confirmed brain and/or leptomeningeal metastases Prior androgen deprivation therapy or orchiectomy for prostate cancer Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater Other uncontrolled intercurrent illness Treatment with immunotherapy against prostate cancer Clinically significant cardiovascular disease 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<br>Dendritic Cells DCVAC/PCA Experimental therapy | Biological: Dendritic Cells DCVAC/PCa<br>* DCVAC/PCa Experimental therapy<br>|
| No Intervention: Standard Therapy<br>No Intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40 |  | 40 Weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

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