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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Dendritic Cells DCVAC/PCa
Standard radiotherapy
Sponsored by
SOTIO a.s.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Immunotherapy, Prostate Cancer, Biological, Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nemocnice Jihlava,Urologické oddělení,
  • Fakultní nemocnice Olomouc
  • FN Ostrava, Onkologická klinika
  • FNKV Klinika radiologie a onkologie
  • FN Motol
  • Nemocnice Na Bulovce

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCVAC/PCa arm post radiotherapy

Standard radiotherapy

Arm Description

Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy

Standard care

Outcomes

Primary Outcome Measures

Number of Prostate Specific Antigen (PSA) failures in 5 years
PSA failure per Phoenix criteria of increase of 2ng/mL over nadir

Secondary Outcome Measures

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
Frequency of Adverse Events
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
Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy

Full Information

First Posted
April 4, 2014
Last Updated
November 12, 2018
Sponsor
SOTIO a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT02107430
Brief Title
Phase II Study of DCVAC/PCa After Primary Radiotherapy for Patients With High Risk Localized Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOTIO a.s.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Immunotherapy, Prostate Cancer, Biological, Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCVAC/PCa arm post radiotherapy
Arm Type
Experimental
Arm Description
Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy
Arm Title
Standard radiotherapy
Arm Type
Active Comparator
Arm Description
Standard care
Intervention Type
Biological
Intervention Name(s)
Dendritic Cells DCVAC/PCa
Intervention Description
DCVAC/PCa arm post radiotherapy
Intervention Type
Radiation
Intervention Name(s)
Standard radiotherapy
Intervention Description
radiotherapy
Primary Outcome Measure Information:
Title
Number of Prostate Specific Antigen (PSA) failures in 5 years
Description
PSA failure per Phoenix criteria of increase of 2ng/mL over nadir
Time Frame
Enrollment up to 260 weeks
Secondary Outcome Measure Information:
Title
Proportion of Patients without use of salvage therapy within 5 years
Description
Calculation of the proportion of patients without use of salvage therapy within 5 years
Time Frame
Enrollment up to 260 weeks
Title
Frequency of Adverse Events
Description
Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events
Time Frame
enrollment up to 260 weeks
Title
Proportion of Patients without Objective disease progression within 5 years
Description
Proportion of patients who do not have a >2ng/mL elevation in PSA or require salvage therapy
Time Frame
Enrollment up to 260 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Scheiner
Organizational Affiliation
Sotio Biotech Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nemocnice Jihlava,Urologické oddělení,
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
FN Ostrava, Onkologická klinika
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
FNKV Klinika radiologie a onkologie
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
FN Motol
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Nemocnice Na Bulovce
City
Praha 8
ZIP/Postal Code
180 00
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=SP004

Learn more about this trial

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

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