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Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer

NCT02064582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-10-12

Study results available
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Summary

The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.

Conditions

Interventions

DRUG

Enzalutamide

160mg by mouth each day

DRUG

Leuprolide acetate

22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months

RADIATION

radiation

External beam radiation will be delivered as per standard radiation therapy protocol

Sponsors & Collaborators

  • Astellas Pharma US, Inc.

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Kevin D Courtney, MD, PhD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2018-06-09
Completion
2018-06-09
FDA Drug
Yes

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 NCT02064582 on ClinicalTrials.gov