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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: Dendritic Cells DCVAC/PCa; Radiation: Standard radiotherapy

• Registration Number: NCT02107430
• Lead Sponsor: SOTIO a.s.

Brief 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.

Detailed Description

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2013-09
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Status Verified: 2018-09
• Study Completion: 2018-10
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard radiotherapy	Standard radiotherapy	Standard care
Standard radiotherapy	Dendritic Cells DCVAC/PCa	Standard care
DCVAC/PCa arm post radiotherapy	Dendritic Cells DCVAC/PCa	Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Nemocnice Jihlava,Urologické oddělení,; 🇨🇿 Jihlava, Czechia

Fakultní nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

FN Ostrava, Onkologická klinika; 🇨🇿 Ostrava, Czechia

FNKV Klinika radiologie a onkologie; 🇨🇿 Praha 10, Czechia

FN Motol; 🇨🇿 Praha 5, Czechia

Nemocnice Na Bulovce; 🇨🇿 Praha 8, Czechia