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CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer

NCT00075192 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-06-06

No results posted yet for this study

Summary

This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

CP-675,206 and leuprolide acetate and bicalutamide

DRUG

leuprolide acetate and bicalutamide

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Completion
2006-03-31

Countries

  • United States

Study Locations

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Entities

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 NCT00075192 on ClinicalTrials.gov