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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Biological: Dendritic Cells DCVAC/PCa; Drug: Leuprolide acetate; Drug: Goserelin Acetate

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Lupron; Drug: Goserelin Acetate; Standard of Care Hormone Therapy as an Active Comparator; Other Names: Zoladex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with PSA Progression	104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) form C30	0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks
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	0, 16, 28, 40, 52, 52, 65, 78, 91, 104 weeks

Collaborators and Investigators

• Sponsor: SOTIO a.s.
• Investigators: Study Director: Tomas Scheiner, PhD, Sotio-Accord

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 8, 2014

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Vaccine; Immunotherapy; Prostate Cancer; Androgen Deprivation Therapy; Biological
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide; Goserelin
• Other Study ID Numbers: SP002; 2011-004986-34 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No