Phase II Study of DCVAC/PCa Added After Radical Primary Prostatectomy for Patients With Localized Prostate Cancer
Phase 2
Completed
- Conditions
- Prostate Cancer
- Interventions
- Biological: Dendritic Cells DCVAC/PCa
- Registration Number
- NCT02107404
- Lead Sponsor
- SOTIO a.s.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCVAC/PCa Arm Dendritic Cells DCVAC/PCa Dendritic Cells DCVAC/PCA Experimental therapy
- Primary Outcome Measures
Name Time Method Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40 40 Weeks
- Secondary Outcome Measures
Name Time Method Number of Patients requiring further therapy at 2 years 104 Weeks Proportion of patients with progressive increase in PSA within 2 years of randomization 104 Weeks Overall survival 104 Weeks Change in PSA Doubling Time during Follow-up from week 40 to 2 years after randomization 104 Weeks Proportion of Patients with Objective disease progression within 2 years 104 Weeks Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization 104 Weeks Frequency of Adverse Events 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks Proportion of patients after RPE with biochemical relapse within 2 years of randomization 104 Weeks