Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments dendritic cells dcvac/pca, standard radiotherapy
Phase phase 2
Sponsor Sotio a.s.
Start date March 2012
End date September 2013
Trial size 62 participants
Trial identifier NCT02107430, 2011-004967-65, SP004

Summary

The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA progression times within 5 years for patients with high risk localized 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)
Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy
dendritic cells dcvac/pca
DCVAC/PCa arm post radiotherapy
(Active Comparator)
Standard care
dendritic cells dcvac/pca
DCVAC/PCa arm post radiotherapy
standard radiotherapy
radiotherapy

Primary Outcomes

Measure
Number of Prostate Specific Antigen (PSA) failures in 5 years
time frame: 260 weeks

Secondary Outcomes

Measure
Proportion of Patients without use of salvage therapy within 5 years
time frame: 260 weeks
Frequency of Adverse Events
time frame: 0, 2, 11, 13, 17, 21, 25, 29, 33, 37, 41, 45, 57, 69, 81, 93, 105, 166, 218, 260 weeks
Proportion of Patients without Objective disease progression within 5 years
time frame: 260 weeks

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Male 18 years and older - Histologically confirmed localized prostate cancer of high risk or very high risk fulfilling at least one of the following: T3-T4 stage or Gleason Score 8-10 or PSA level above 20 ng/ml - Indication for prostate cancer radical radiotherapy - Neo-adjuvant androgen androgen-deprivation therapy due to prostate cancer using Luteinizing-hormone-releasing hormone (LHRH) analogues ongoing for at least two months and not longer than 12 months prior randomization - Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: - Primary surgical treatment of prostate cancer - Prior or ongoing chemotherapy for prostate cancer - Participation in other clinical study or administration of other evaluated drug within 30 day prior screening - Unresolved lasting obstruction of urinary system - Other uncontrolled inter-current illness - Treatment with immunotherapy against Prostate Cancer - Clinically significant cardiovascular disease - History of primary immunodeficiency - 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 Localized High-risk Prostate Cancer After Primary Radiotherapy
Description Treatment post radical primary prostatectomy Treatment post standard radiotherapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sotio a.s..