NCT02107391

Brief Summary

The purpose of this study is to determine whether DCVAC/PCa added onto hormone therapy can improve PSA progression times for patients with Metastatic Prostate Cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

9 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

March 1, 2012

Completed
2.1 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
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 24, 2017

Status Verified

June 1, 2015

Enrollment Period

3.8 years

First QC Date

April 4, 2014

Last Update Submit

May 23, 2017

Conditions

Prostate Cancer

Keywords

ImmunotherapyProstate CancerBiologicalVaccineAndrogen Deprivation Therapy

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with PSA Progression

    104 weeks

Secondary Outcomes (5)

  • Proportion of patients with Progression of Disease

    0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks

  • Frequency of Adverse Events

    0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks

  • Frequency of Skeletal Related Events

    0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks

  • Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30

    0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

  • Changes in Pain assessed by EORTC QLQ-C30

    0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

Study Arms (2)

DCVAC/PCA added Standard Hormone Therapy

EXPERIMENTAL

Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy

Biological: Dendritic Cells DCVAC/PCa

Standard of Care Hormone Therapy

ACTIVE COMPARATOR

Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate

Drug: Leuprolide acetateDrug: Goserelin Acetate

Interventions

Dendritic Cells DCVAC/PCaBIOLOGICAL

Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy

DCVAC/PCA added Standard Hormone Therapy
Leuprolide acetateDRUG

Standard of Care Hormone Therapy as an Active Comparator

Also known as: Lupron
Standard of Care Hormone Therapy
Goserelin AcetateDRUG

Standard of Care Hormone Therapy as an Active Comparator

Also known as: Zoladex
Standard of Care Hormone Therapy

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 prostate adenocarcinoma
  • Presence of bone or soft tissue metastasis (by CT or PET or MRI and/or scintigraphy)
  • Androgen deprivation therapy using Luteinizing-hormone-releasing hormone ( LHRH) analogues commenced at least one month and at most three months prior randomization or orchiectomy performed at least one month and at most three months prior randomization
  • Serum testosterone level at screening (≤ 1.7 nmol/l, resp. ≤ 50 ng/dL)
  • Eastern Cooperative Oncology Group (ECOG) 0-2

You may not qualify if:

  • Confirmed brain and/or leptomeningeal metastases
  • Prior or ongoing chemotherapy 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 (9)

Unknown Facility

Jablonec nad Nisou, Czechia

Location

Unknown Facility

Jihlava, Czechia

Location

Unknown Facility

Liberec, Czechia

Location

Unknown Facility

Mníšek pod Brdy, Czechia

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Pilsen, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Ústí nad Labem, Czechia

Location

Unknown Facility

Zlín, Czechia

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

LeuprolideGoserelin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

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

March 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

May 24, 2017

Record last verified: 2015-06

Locations

CZ(9)