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

NCT02107430 | Completed Phase 2

• 2 other identifiers: SP0042011-004967-65
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 6

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.

Conditions

Prostate Cancer

Keywords

Immunotherapy; Prostate Cancer; Biological, Vaccine

Outcome Measures

Primary Outcomes (1)

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

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

  Enrollment up to 260 weeks

Secondary Outcomes (3)

• Proportion of Patients without use of salvage therapy within 5 years

  Enrollment up to 260 weeks

• Frequency of Adverse Events

  enrollment up to 260 weeks

• Proportion of Patients without Objective disease progression within 5 years

  Enrollment up to 260 weeks

Study Arms (2)

DCVAC/PCa arm post radiotherapy

EXPERIMENTAL

Dendritic Cells DCVAC/PCa Experimental therapy post radiotherapy

Biological: Dendritic Cells DCVAC/PCa

Standard radiotherapy

ACTIVE COMPARATOR

Standard care

Biological: Dendritic Cells DCVAC/PCa; Radiation: Standard radiotherapy

Interventions

Dendritic Cells DCVAC/PCa BIOLOGICAL

DCVAC/PCa arm post radiotherapy

DCVAC/PCa arm post radiotherapy; Standard radiotherapy

Standard radiotherapy RADIATION

radiotherapy

Standard radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SOTIO a.s.: lead

Study Sites (6)

Nemocnice Jihlava,Urologické oddělení,

Jihlava, 586 33, Czechia

Location

Fakultní nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

FN Ostrava, Onkologická klinika

Ostrava, 708 52, Czechia

Location

FNKV Klinika radiologie a onkologie

Prague, 100 34, Czechia

Location

FN Motol

Prague, 150 06, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 00, Czechia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tomas Scheiner

  Sotio Biotech Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: March 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available 12 months after study completion.
• Access Criteria: No specific access criteria are required

Locations

CZ (6)