Trial | NCT02105675  Report issue

Title

Phase II Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer
Randomized, Open-label, Parallel-group, Multi-centre Phase II Clinical Trial of Active Cellular Immunotherapy With Preparation DCVAC/PCa in Patients With Castrate-resistant Prostate Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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
Study Started
Feb 29
2012
Primary Completion
Mar 31
2014
Study Completion
Feb 20
2017
Last Update
May 24
2017

Biological Dendritic Cells DCVAC/PCa

DCVAC/PCa is the experimental therapy added on to Docetaxel

Drug Docetaxel

Docetaxel is Standard of Care First Line Chemotherapy

  • Other names: taxotere

DCVAC/PCa add on to Standard of Care Experimental

Combination therapy with Dendritic Cells DCVAC/PCa and Standard of Care

Standard of Care Active Comparator

Docetaxel as an Active Comparator

Criteria 

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
No Results Posted