Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Biological: Dendritic Cells DCVAC/PCa; Radiation: Standard radiotherapy

Detailed Description

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Jihlava, Czechia, 586 33
    • Nemocnice Jihlava,Urologické oddělení,
  • Olomouc, Czechia, 775 20
    • Fakultni Nemocnice Olomouc
  • Ostrava, Czechia, 708 52
    • FN Ostrava, Onkologická klinika
  • Praha 10, Czechia, 100 34
    • FNKV Klinika radiologie a onkologie
  • Praha 5, Czechia, 150 06
    • FN Motol
  • Praha 8, Czechia, 180 00
    • Nemocnice Na Bulovce

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCVAC/PCa arm post radiotherapy; Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy	Biological: Dendritic Cells DCVAC/PCa; DCVAC/PCa arm post radiotherapy
Active Comparator: Standard radiotherapy; Standard care	Biological: Dendritic Cells DCVAC/PCa; DCVAC/PCa arm post radiotherapy; Radiation: Standard radiotherapy; radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Prostate Specific Antigen (PSA) failures in 5 years	PSA failure per Phoenix criteria of increase of 2ng/mL over nadir	Enrollment up to 260 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients without use of salvage therapy within 5 years	Calculation of the proportion of patients without use of salvage therapy within 5 years	Enrollment up to 260 weeks
Frequency of Adverse Events	Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events	enrollment up to 260 weeks
Proportion of Patients without Objective disease progression within 5 years	Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy	Enrollment up to 260 weeks

Collaborators and Investigators

• Sponsor: SOTIO a.s.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Immunotherapy; Prostate Cancer; Biological, Vaccine
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SP004; 2011-004967-65 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Clinical trial results will be reported as required by European legislation in clinicaltrialsregister.eu.
• IPD Sharing Time Frame: Data will be available 12 months after study completion.
• IPD Sharing Access Criteria: No specific access criteria are required