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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107404
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
SOTIO Biotech ( SOTIO a.s. )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Dendritic Cells DCVAC/PCa Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40 [ Time Frame: 40 Weeks ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107404


Locations
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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
Sponsors and Collaborators
SOTIO a.s.
Investigators
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Study Director: Tomas Scheiner, PhD Sotio Accord
More Information
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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02107404    
Other Study ID Numbers: SP003
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: June 2015
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Immunotherapy
Prostate Cancer
Biological
Vaccine
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases