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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02107391
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
SOTIO Biotech ( SOTIO a.s. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Biological: Dendritic Cells DCVAC/PCa Drug: Leuprolide acetate Drug: Goserelin Acetate Phase 2

Detailed Description:
Use of vaccine to improve Prostate Specific Antigen (PSA) levels.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DCVAC/PCA added Standard Hormone Therapy
Combination therapy with Dendritic Cells DCVAC/PCa added on to a Standard of Care Hormone Therapy
 Biological: Dendritic Cells DCVAC/PCa
Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy
Active Comparator: Standard of Care Hormone Therapy
Standard of Care Hormone Therapy as an Active Comparator Goserelin Acetate Leuprolide Acetate
 Drug: Leuprolide acetate
Standard of Care Hormone Therapy as an Active Comparator
Other Name: Lupron

Drug: Goserelin Acetate
Standard of Care Hormone Therapy as an Active Comparator
Other Name: Zoladex


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with PSA Progression [ Time Frame: 104 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients with Progression of Disease [ Time Frame: 0, 6, 16, 28, 40, 52, 65, 78, 91, 104 weeks ]
  2. Frequency of Adverse Events [ Time Frame: 0, 2, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 52, 65, 78, 91, 104 weeks ]
  3. 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 ]
  4. Changes in Quality of Life (QOL) assessed by EORTC QLQ-C30 [ Time Frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks ]
    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30

  5. Changes in Pain assessed by EORTC QLQ-C30 [ Time Frame: 0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks ]
    Pain Scale from European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107391


Locations
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Czechia
Jablonec nad Nisou, Czechia
Jihlava, Czechia
Liberec, Czechia
Mnisek pod Brdy, Czechia
Olomouc, Czechia
Plzen, Czechia
Praha 10, Czechia
Praha 4, Czechia
Praha 5, Czechia
Praha 8, Czechia
Usti nad Labem, Czechia
Zlin, Czechia
Sponsors and Collaborators
SOTIO a.s.
Investigators
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Study Director: Tomas Scheiner, PhD Sotio-Accord
More Information
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Responsible Party: SOTIO a.s.
ClinicalTrials.gov Identifier: NCT02107391    
Other Study ID Numbers: SP002
2011-004986-34 ( EudraCT Number )
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: June 2015
Keywords provided by SOTIO Biotech ( SOTIO a.s. ):
Immunotherapy
Prostate Cancer
Biological
Vaccine
Androgen Deprivation Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
 Male Urogenital Diseases
Leuprolide
Goserelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents