IRB #

IRB00010479

Title

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

Principal Investigator

Tomasz Beer

Study Purpose

The main purpose of this study is to find out if DCVAC/PCa when given with standard of care chemotherapy makes people with prostate cancer live longer than giving the standard of care chemotherapy and a placebo. DCVAC/PCa is an immunotherapy - this means that it is similar to a vaccine in that it is designed to train your white blood cells to fight against your disease.

Medical Condition(s)

Metastatic Castration-Resistant Prostate Cancer (CRPC) that is eligible to receive docetaxel chemotherapy.

Eligibility Criteria

Prostate Cancer that has spread outside the prostate and is no longer responding to hormonal therapies.
Eligible to receive Standard of Care chemotherapy.
Patients who are HIV or HTLV positive, or have active heptatitis B, hepatitis C, or syphilis are excluded.

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

15 months

Minors Included

No

Contact

OHSU Knight Clinical Trials Information Line
trials@ohsu.edu
(503) 494-1080

Sponsor

SOTIO

Recruitment End

08/01/2017

Compensation Provided

No


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