NCT02107404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2012

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
Last Updated

May 24, 2017

Status Verified

June 1, 2015

Enrollment Period

3.2 years

First QC Date

April 4, 2014

Last Update Submit

May 23, 2017

Conditions

Prostate Cancer

Keywords

ImmunotherapyProstate CancerBiologicalVaccine

Outcome Measures

Primary Outcomes (1)

  • Change in Prostate Specific Antigen (PSA) Doubling Time from randomization to week 40

    40 Weeks

Secondary Outcomes (8)

  • Change in PSA Doubling Time during Follow-up from week 40 to 2 years after 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 with Objective disease progression within 2 years

    104 Weeks

  • Number of Patients requiring further therapy at 2 years

    104 Weeks

  • Comparison of PSA Doubling Time in Treatment Phase with Immunotherapy with the Value Prior to Randomization

    104 Weeks

  • +3 more secondary outcomes

Study Arms (2)

DCVAC/PCa Arm

EXPERIMENTAL

Dendritic Cells DCVAC/PCA Experimental therapy

Biological: Dendritic Cells DCVAC/PCa

Standard Therapy

NO INTERVENTION

No Intervention

Interventions

Dendritic Cells DCVAC/PCaBIOLOGICAL

DCVAC/PCa Experimental therapy

DCVAC/PCa Arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Jablonec nad Nisou, Czechia

Location

Unknown Facility

Jihlava, Czechia

Location

Unknown Facility

Mníšek pod Brdy, Czechia

Location

Unknown Facility

Nový Jičín, Czechia

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Pilsen, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Uherské Hradiště, Czechia

Location

Unknown Facility

Ústí nad Labem, Czechia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Tomas Scheiner, PhD

    Sotio Accord

    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

April 1, 2012

Primary Completion

June 1, 2015

Study Completion

May 22, 2017

Last Updated

May 24, 2017

Record last verified: 2015-06

Locations

CZ(11)