Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments dendritic cells dcvac/pca, leuprolide acetate, goserelin acetate
Phase phase 2
Sponsor Sotio a.s.
Start date March 2012
End date December 2015
Trial size 63 participants
Trial identifier NCT02107391, 2011-004986-34, SP002

Summary

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.

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 added on to a Standard of Care Hormone Therapy
dendritic cells dcvac/pca
Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy
(Active Comparator)
Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
leuprolide acetate Lupron
Standard of Care Hormone Therapy as an Active Comparator
goserelin acetate Zoladex
Standard of Care Hormone Therapy as an Active Comparator

Primary Outcomes

Measure
Proportion of patients with PSA Progression
time frame: 104 weeks

Secondary Outcomes

Measure
Proportion of patients with Progression of Disease
time frame: 0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks
Frequency of Adverse Events
time frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Frequency of Skeletal Related Events
time frame: 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
time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
Changes in Pain assessed by EORTC QLQ-C30
time frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title 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
Description Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..