Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic 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 hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.

Detailed Description
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Use of vaccine to improve Prostate Specific Antigen (PSA) levels.

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 Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: Dendritic Cells DCVAC/PCa
* Drug: Leuprolide acetate
* Drug: Goserelin Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18 years and older Histologically confirmed prostate adenocarcinoma Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy) Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL) Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: Confirmed brain and/or leptomeningeal metastases Prior or ongoing chemotherapy 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 added Standard Hormone Therapy<br>Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy | Biological: Dendritic Cells DCVAC/PCa<br>* Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy<br>|
| Active Comparator: Standard of Care Hormone Therapy<br>Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate | Drug: Leuprolide acetate<br>* Standard of Care Hormone Therapy as an Active Comparator<br>* Other names: Lupron;Drug: Goserelin Acetate<br>* Standard of Care Hormone Therapy as an Active Comparator<br>* Other names: Zoladex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with PSA Progression |  | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

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