Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer; Prostate Cancer Metastatic
• Interventions: Biological: Dendritic Cells DCVAC/PCa; Drug: Docetaxel

• Registration Number: NCT02105675
• Lead Sponsor: SOTIO a.s.

Brief Summary

The purpose of this study is to determine whether DCVAC/PCa added onto Standard of Care therapy can improve survival times for patients with Metastatic Castration Resistant Prostate Cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Status Verified: 2015-06
• Study Completion: 2017-02-20
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Men aged ≥ 18 years
• Histologically confirmed prostate cancer
• Presence of skeletal metastasis (by CT or PET or MRI)
• Disease progression documented by increasing PSA or two new lesions
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

Exclusion Criteria

• Confirmed brain and/or leptomeningeal metastases
• Prior chemotherapy for prostate cancer
• Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
• Other uncontrolled intercurrent illness
• Treatment with immunotherapy against PCa
• Clinically significant cardiovascular disease
• Active autoimmune disease requiring treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCVAC/PCa add on to Standard of Care	Dendritic Cells DCVAC/PCa	Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care
Standard of Care	Docetaxel	Docetaxel as an Active Comparator

Primary Outcome Measures

Name	Time	Method
Survival rate	135 weeks

Secondary Outcome Measures

Name	Time	Method
Duration to Prostate Specific Antigen (PSA) Progression	135 weeks
Changes in Pain assessed by EORTC QLQ-C30	0, 10, 22, 37, 53, 65 weeks
Incidence of Adverse Events	135 weeks
Changes in Quality of Life (QOL) assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30	0, 10, 22, 37, 53, 65 weeks
Radiographic Progression Free Survival	135 weeks