Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

SOTIO

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer Metastatic; Prostate Cancer

Treatments: Biological: Dendritic Cells DCVAC/PCa; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02105675

SP001

2011-004735-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

DCVAC/PCa add on to Standard of Care

Experimental group

Description:

Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care

Treatment:

Biological: Dendritic Cells DCVAC/PCa

Standard of Care

Active Comparator group

Description:

Docetaxel as an Active Comparator

Treatment:

Drug: Docetaxel