Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant 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 onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer

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 Castrate-resistant Prostate Cancer

Conditions
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Prostate Cancer, Prostate Cancer Metastatic

Intervention / Treatment
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* Biological: Dendritic Cells DCVAC/PCa
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged ≥ 18 years Histologically confirmed prostate cancer Presence of skeletal metastasis (by CT or PET or MRI) Disease progression documented by increasing PSA or two new lesions Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Exclusion Criteria: Confirmed brain and/or leptomeningeal metastases Prior chemotherapy for prostate cancer Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater Other uncontrolled intercurrent illness Treatment with immunotherapy against PCa 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 add on to Standard of Care<br>Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care | Biological: Dendritic Cells DCVAC/PCa<br>* DCVAC/PCa is the experimental therapy added on to Docetaxel<br>|
| Active Comparator: Standard of Care<br>Docetaxel as an Active Comparator | Drug: Docetaxel<br>* Docetaxel is Standard of Care First Line Chemotherapy<br>* Other names: taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 135 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

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