Clinical trial NCT02107430: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Immunotherapy
Prostate Cancer
Biological, Vaccine
Lead sponsor: Sotio Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Number of Prostate Specific Antigen (PSA) failures in 5 years
timeFrame: Enrollment up to 260 weeks
Secondary outcomes:
measure: Proportion of Patients without use of salvage therapy within 5 years
timeFrame: Enrollment up to 260 weeks
measure: Frequency of Adverse Events
timeFrame: enrollment up to 260 weeks
measure: Proportion of Patients without Objective disease progression within 5 years
timeFrame: Enrollment up to 260 weeks
Other outcomes:
Locations:
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava,Urologické oddělení,
city: Olomouc
country: Czechia
facility: Fakultní nemocnice Olomouc
city: Ostrava
country: Czechia
facility: FN Ostrava, Onkologická klinika
city: Praha 10
country: Czechia
facility: FNKV Klinika radiologie a onkologie
city: Praha 5
country: Czechia
facility: FN Motol
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
Study officials:
affiliation: Sotio Biotech Inc.
name: Tomas Scheiner
role: STUDY_DIRECTOR
References: