Trial Information

Summary: VITAL-2 GVAX ® Immunotherapy for Prostate Cancer Trial (G-0034)

VITAL-2 is an open-label trial comparing investigational GVAX ® immunotherapy in combination with Docetaxel and prednisone in Taxane-naïve patients with Metastatic Hormone-Refractory Prostate Cancer with pain.

Objective

The primary objective of this study is to compare the duration of survival between the two treatment arms: GVAX ® Immunotherapy for Prostate Cancer in combination with Taxotere® vs. Taxotere® and prednisone.

Eligibility:

• Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
• Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
• Detectable metastases (cancer that has spread outside the prostate)
• ECOG performance status =2 (Performance status of 3 if due to bone pain)
• Any Gleason score (a measure of the aggressiveness of prostate cancer)
• Only one prior treatment with systemic chemotherapy
• No prior treatment with gene therapy
• Taxane Naïve
• Experiencing cancer-related pain

Treatment:

Patients will be randomized to one of two treatment arms:

Arm 1: Cancer immunotherapy injections in combination with Taxotere® every 21 days over 10 cycles followed by monthly cancer immunotherapy injections alone for life or until a new treatment for prostate cancer begins.

Arm 2: Taxotere® administered every 21 days and prednisone daily for 10 cycles.

Patients will then be followed for the duration of their life for survival/long-term follow-up.

Enrollment Information

For more information, call 1.800.648.6747 ext 3210

If you would like to learn more about participating in this study, please send an e-mail message using the form below.