Suspended

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

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What is being tested

Immunotherapy with allogeneic prostate vaccine

+ Chemotherapy (Taxotere and prednisone)

BiologicalDrug
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorCell Genesys
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00089856
Principal SponsorCell Genesys
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

626 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Immunotherapy

Group II

Standard of care - chemotherapy

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 126 locations

Suspended

Central Alabama Oncology, LLC

Alabaster, United StatesSee the location
Suspended

Alaska Clinical Research Center

Anchorage, United States
Suspended

Palo Verde Hematology/Oncology

Glendale, United States
Suspended

Mayo Clinic Scottsdale

Scottsdale, United States
Suspended126 Study Centers