Clinical trial NCT02107404: Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
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
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: 150
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 doubling times for patients with localized Prostate Cancer.


Eligibility 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

Primary outcomes:
measure: Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40
timeFrame: 40 Weeks
Secondary outcomes:
measure: Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization
timeFrame: 104 Weeks
measure: Frequency of Adverse Events
timeFrame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
measure: Proportion of Patients with Objective disease progression within 2 years
timeFrame: 104 Weeks
measure: Number of Patients requiring further therapy at 2 years
timeFrame: 104 Weeks
measure: Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization
timeFrame: 104 Weeks
measure: Proportion of patients after RPE with biochemical relapse within 2 years of randomization
timeFrame: 104 Weeks
measure: Proportion of patients with progressive increase in PSA within 2 years of randomization
timeFrame: 104 Weeks
measure: Overall survival
timeFrame: 104 Weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
city: Hradec Kralove
country: Czechia
city: Jablonec nad Nisou
country: Czechia
city: Jihlava
country: Czechia
city: Mnisek pod Brdy
country: Czechia
city: Novy Jicin
country: Czechia
city: Olomouc
country: Czechia
city: Plzen
country: Czechia
city: Praha 10
country: Czechia
city: Praha 4
country: Czechia
city: Praha 5
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Usti nad Labem
country: Czechia
Study officials:
affiliation: Sotio Accord
name: Tomas Scheiner, PhD
role: STUDY_DIRECTOR
References: