Trial Information

Summary: VITAL-1 GVAX® Prostate Cancer Immunotherapy Trial (G-0029)

VITAL-1 is a Phase 3 clinical trial comparing an investigational prostate cancer immunotherapy to Taxotere® chemotherapy in metastatic HRPC (Hormone-Refractory Prostate Cancer) patients who are asymptomatic for cancer-related pain.

Objective:

• To compare the duration of survival between the two treatment arms: GVAX® immunotherapy for prostate cancer versus Taxotere® chemotherapy 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
• ECOG performance status 0-2
• Any Gleason score
• No prior treatment with chemotherapy for prostate cancer
• No prior treatment with gene therapy
• No significant cancer related pain.

Treatment:

Patients will be randomized to one of two treatment arms:

ARM 1: Initial cancer immunotherapy treatment is 13 bi-weekly injections over 24 weeks, followed by monthly cancer immunotherapy injections for life or until a new treatment for prostate cancer begins.

ARM 2: Taxotere® administered every 21 days and prednisone daily for 9 cycles.

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.