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Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Czechia
Study Type
Interventional
Intervention
Dendritic Cells DCVAC/PCa
Leuprolide acetate
Goserelin Acetate
Sponsored by
SOTIO a.s.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Immunotherapy, Prostate Cancer, Biological, Vaccine, Androgen Deprivation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DCVAC/PCA added Standard Hormone Therapy

Standard of Care Hormone Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of patients with PSA Progression

Secondary Outcome Measures

Proportion of patients with Progression of Disease
Frequency of Adverse Events
Frequency of Skeletal Related Events
Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Changes in Pain assessed by EORTC QLQ-C30
Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30

Full Information

First Posted
April 4, 2014
Last Updated
May 23, 2017
Sponsor
SOTIO a.s.
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1. Study Identification

Unique Protocol Identification Number
NCT02107391
Brief Title
Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer
Official Title
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Combination With Hormone Therapy in Patients With Metastatic Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SOTIO a.s.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Immunotherapy, Prostate Cancer, Biological, Vaccine, Androgen Deprivation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCVAC/PCA added Standard Hormone Therapy
Arm Type
Experimental
Arm Description
Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy
Arm Title
Standard of Care Hormone Therapy
Arm Type
Active Comparator
Arm Description
Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
Intervention Type
Biological
Intervention Name(s)
Dendritic Cells DCVAC/PCa
Intervention Description
Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate
Other Intervention Name(s)
Lupron
Intervention Description
Standard of Care Hormone Therapy as an Active Comparator
Intervention Type
Drug
Intervention Name(s)
Goserelin Acetate
Other Intervention Name(s)
Zoladex
Intervention Description
Standard of Care Hormone Therapy as an Active Comparator
Primary Outcome Measure Information:
Title
Proportion of patients with PSA Progression
Time Frame
104 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with Progression of Disease
Time Frame
0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks
Title
Frequency of Adverse Events
Time Frame
0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Title
Frequency of Skeletal Related Events
Time Frame
0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks
Title
Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30
Description
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Time Frame
0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
Title
Changes in Pain assessed by EORTC QLQ-C30
Description
Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30
Time Frame
0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Scheiner, PhD
Organizational Affiliation
Sotio-Accord
Official's Role
Study Director
Facility Information:
City
Jablonec nad Nisou
Country
Czechia
City
Jihlava
Country
Czechia
City
Liberec
Country
Czechia
City
Mnisek pod Brdy
Country
Czechia
City
Olomouc
Country
Czechia
City
Plzen
Country
Czechia
City
Praha 10
Country
Czechia
City
Praha 4
Country
Czechia
City
Praha 5
Country
Czechia
City
Praha 8
Country
Czechia
City
Usti nad Labem
Country
Czechia
City
Zlin
Country
Czechia

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer

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