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

NCT ID: NCT02107391

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCVAC/PCA added Standard Hormone Therapy

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

Group Type: EXPERIMENTAL

Dendritic Cells DCVAC/PCa

Intervention Type: BIOLOGICAL

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

Standard of Care Hormone Therapy

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

Group Type: ACTIVE_COMPARATOR

Leuprolide acetate

Intervention Type: DRUG

Standard of Care Hormone Therapy as an Active Comparator

Goserelin Acetate

Intervention Type: DRUG

Standard of Care Hormone Therapy as an Active Comparator

Interventions

Dendritic Cells DCVAC/PCa

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

Intervention Type: BIOLOGICAL

Leuprolide acetate

Standard of Care Hormone Therapy as an Active Comparator

Intervention Type: DRUG

Goserelin Acetate

Standard of Care Hormone Therapy as an Active Comparator

Intervention Type: DRUG

Other Intervention Names

Lupron; Zoladex

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

SOTIO a.s.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tomas Scheiner, PhD

Role: STUDY_DIRECTOR

Sotio-Accord

Locations

Jablonec nad Nisou, , Czechia

Jihlava, , Czechia

Liberec, , Czechia

Mníšek pod Brdy, , Czechia

Olomouc, , Czechia

Pilsen, , Czechia

Prague, , Czechia

Ústí nad Labem, , Czechia

Zlín, , Czechia

Countries

Czechia

Other Identifiers

2011-004986-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SP002

Identifier Type: -

Identifier Source: org_study_id