Overview

This trial is active, not recruiting.

Conditions prostate cancer, prostate cancer metastatic
Treatments dendritic cells dcvac/pca, docetaxel
Phase phase 2
Sponsor Sotio a.s.
Start date February 2012
End date March 2014
Trial size 60 participants
Trial identifier NCT02105675, 2011-004735-32, SP001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
dendritic cells dcvac/pca
DCVAC/PCa is the experimental therapy added on to Docetaxel
(Active Comparator)
Docetaxel as an Active Comparator
docetaxel taxotere
Docetaxel is Standard of Care First Line Chemotherapy

Primary Outcomes

Measure
Survival rate
time frame: 135 weeks

Secondary Outcomes

Measure
Radiographic Progression Free Survival
time frame: 135 weeks
Duration to Prostate Specific Antigen (PSA) Progression
time frame: 135 weeks
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
time frame: 0, 10, 22, 37, 53, 65 weeks
Changes in Pain assessed by EORTC QLQ-C30
time frame: 0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events
time frame: 135 weeks

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..