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Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer

NCT00170157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2017-05-15

Study results available
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Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide acetate, goserelin, flutamide, or bicalutamide may lessen the amount of androgens made by the body. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving antihormone therapy together with ipilimumab may kill more tumor cells.

PURPOSE: This randomized phase II trial is study how well giving hormone therapy and ipilimumab together works in treating patients with advanced prostate cancer.

Conditions

  • Prostate Adenocarcinoma
  • Prostate Carcinoma
  • Recurrent Prostate Carcinoma
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer

Interventions

DRUG

Bicalutamide

Given orally

DRUG

Flutamide

Given orally

DRUG

Goserelin Acetate

Given SC

DRUG

Ipilimumab

Given IV

DRUG

Leuprolide Acetate

Given IM

OTHER

Pharmacological Study

Correlative study

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Eugene Kwon · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2011-04-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00170157 on ClinicalTrials.gov