GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00089856

Enrollment

626

Registered

2004-08-18

Start date

2004-07-31

Completion date

2008-10-31

Last updated

2008-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel, Prednisone, Vaccine, Allogeneic cells, Advanced Prostate Cancer

Brief summary

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

Interventions

BIOLOGICALImmunotherapy with allogeneic prostate vaccine

Immunotherapy with allogeneic prostate vaccine

DRUGChemotherapy (Taxotere and prednisone)

Chemotherapy (Taxotere and prednisone)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 * Any Gleason score * ECOG performance status 0-2

Exclusion criteria

* Prior treatment with chemotherapy * Prior Immunotherapy * Prior treatment with gene therapy * Significant cancer related pain

Design outcomes

Primary

Measure	Time frame
Survival	0

Secondary

Measure	Time frame
Bone pain and bone related events	0

Countries

Belgium, Canada, France, Germany, Netherlands, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026