MedTrace Logo

Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

NCT00526591 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-12-06

Study results available
· View outcomes & findings →

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer.

Conditions

Interventions

DRUG

Everolimus

Patients will receive arm-specific dosage of Everolimus daily continuously for 8 week

PROCEDURE

conventional surgery

Radical prostatectomy with bilateral pelvic lymphadenectomy will be performed within 10 days of the completion of week 8 on RAD-001 (Everolimus).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Jorge A. Garcia, MD

    lead OTHER

Principal Investigators

  • Jorge A. Garcia, MD · Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00526591 on ClinicalTrials.gov