Study to Allow for Second Treatment Cycle of DCVAC in Patients With Localized Prostate Cancer

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

Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression

The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Same as brief summary

Study Type

Interventional

Enrollment (Actual)

24

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
      • Hradec Kralove, Czechia
      • Jablonec nad Nisou, Czechia
      • Novy Jicin, Czechia
      • Olomouc, Czechia
      • Prague 4, Czechia
      • Prague 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 prostate adenocarcinoma Stage pathological tumor-2 (pT2)
  • Post radical Primary Prostatectomy
  • Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease

Exclusion Criteria:

  • Prior androgen deprivation therapy for prostate cancer
  • Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
  • Other uncontrolled intercurrent illness
  • Treatment with immunotherapy against PCa
  • 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety evaluation of the second cycle of DCVAC
Time Frame: 52 weeks
Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Prostate Specific Antigen (PSA) Doubling Time
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

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

Sponsor

SOTIO a.s.

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)

December 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

March 20, 2017

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 13, 2014

First Posted (ESTIMATE)

May 14, 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

  • SP010
  • 2013-003809-26 (EUDRACT_NUMBER)

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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