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

SOTIO a.s.62 enrolled

Overview

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.

Treatment post radical primary prostatectomy Treatment post standard radiotherapy

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Dendritic Cells DCVAC/PCaBIOLOGICAL

DCVAC/PCa arm post radiotherapy

Standard radiotherapyRADIATION

radiotherapy

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Nemocnice Jihlava,Urologické oddělení,

Jihlava, Czechia

Fakultní nemocnice Olomouc

Olomouc, Czechia

FN Ostrava, Onkologická klinika

Ostrava, Czechia

FNKV Klinika radiologie a onkologie

Prague, Czechia

Outcomes

Primary Outcomes

Number of Prostate Specific Antigen (PSA) failures in 5 years

PSA failure per Phoenix criteria of increase of 2ng/mL over nadir

Time frame: Enrollment up to 260 weeks

Secondary Outcomes

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

Time frame: Enrollment up to 260 weeks

Frequency of Adverse Events

Safety profile as defined by the nature, incidence, duration, severity and outcome of adverse events

Time frame: enrollment up to 260 weeks

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

Time frame: Enrollment up to 260 weeks

Data from ClinicalTrials.gov

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