Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer

May 23, 2017 updated by: SOTIO a.s.

Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial With Active Cellular Immunotherapy DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy

The purpose of this study is to determine whether DCVAC/PCa added after radical primary prostatectomy can improve PSA doubling times for patients with localized Prostate Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
      • Hradec Kralove, Czechia
      • Jablonec nad Nisou, Czechia
      • Jihlava, Czechia
      • Mnisek pod Brdy, Czechia
      • Novy Jicin, Czechia
      • Olomouc, Czechia
      • Plzen, Czechia
      • Praha 10, Czechia
      • Praha 4, Czechia
      • Praha 5, Czechia
      • Uherske Hradiste, Czechia
      • Usti nad Labem, Czechia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 pT2 prostate cancer
  • Post radical prostatectomy
  • PSA values measured after the value greater than 0.020 ng/mL resulted in PSA doubling time (PSADT) equal or less than 12 months
  • Salvage radiotherapy naïve with PSA increase within 2 years or after salvage radiotherapy with PSA not higher than 1 ng/ml
  • Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

  • Confirmed brain and/or leptomeningeal metastases
  • Prior androgen deprivation therapy or orchiectomy 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCVAC/PCa Arm
Dendritic Cells DCVAC/PCA Experimental therapy
Biological: Dendritic Cells DCVAC/PCa
DCVAC/PCa Experimental therapy
No Intervention: Standard Therapy
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
Time Frame: 40 Weeks
40 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of Adverse Events
Time Frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
Time Frame: 104 Weeks
104 Weeks
Proportion of Patients with Objective disease progression within 2 years
Time Frame: 104 Weeks
104 Weeks
Number of Patients requiring further therapy at 2 years
Time Frame: 104 Weeks
104 Weeks
Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
Time Frame: 104 Weeks
104 Weeks
Proportion of patients after RPE with biochemical relapse within 2 years of randomization
Time Frame: 104 Weeks
104 Weeks
Proportion of patients with progressive increase in PSA within 2 years of randomization
Time Frame: 104 Weeks
104 Weeks
Overall survival
Time Frame: 104 Weeks
104 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SOTIO a.s.

Investigators

  • Study Director: Tomas Scheiner, PhD, Sotio Accord

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

May 22, 2017

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP003 (Other Grant/Funding Number: Pediatric Cancer Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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