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Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer

NCT00771017 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-05-25

No results posted yet for this study

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy, such as bicalutamide, leuprolide, and goserelin, may lessen the amount of androgens made by the body. Vaccine therapy may help the body build an effective immune response to kill tumor cells. It is not yet known whether androgen ablation therapy is more effective with or without vaccine therapy in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying androgen ablation therapy to see how well it works when given together with or without vaccine therapy in treating patients with prostate cancer.

Conditions

Interventions

BIOLOGICAL

GVAX prostate cancer vaccine

Given intradermally

DRUG

bicalutamide

Given orally

DRUG

goserelin

Given intramuscularly

DRUG

leuprolide acetate

Given intramuscularly

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Eastern Cooperative Oncology Group

    lead NETWORK

Principal Investigators

  • Charles G. Drake, MD, PhD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  • Michael A. Carducci, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00771017 on ClinicalTrials.gov