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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107430
• Other study ID #: SP004
• Secondary ID: 2011-004967-65
• Status: Completed
• Phase: Phase 2
• Start date: March 2012
• Est. completion date: October 2018

Study information

• Verified date: September 2018
• Source: Sotio a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 2018
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• Dendritic Cells DCVAC/PCa
DCVAC/PCa arm post radiotherapy

Radiation:
• Standard radiotherapy
radiotherapy

Locations

Country	Name	City	State
Czechia	Nemocnice Jihlava,Urologické oddelení,	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

Sponsors (1)

Lead Sponsor	Collaborator
Sotio a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Frequency of Adverse Events	Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events	enrollment up to 260 weeks
Secondary	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