Prostate Cancer Clinical Trial

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

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.

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Full Description

this pilot study will assess the safety and tolerability of combining enzalutamide with an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation
Correlative imaging and tissue biopsy analysis will be performed to assess the radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH) therapy as well as intratumoral androgen signaling

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

histologically proven adenocarcinoma of the prostate within 6 months of screening
Eastern Cooperative Oncology Group(ECOG) score 0-2
adequate organ and and blood marrow function
must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception

Exclusion Criteria:

prior treatment with agents known to have endocrine effects on prostate cancer
treatment with corticosteroids within 4 weeks of enrollment
treatment with androgens within 6 months of enrollment
may not be receiving any other investigational agents
Prostate specific antigen greater than 160ng/dL
history of malignancy( other than non-melanoma skin cancer) within 5 years
uncontrolled intercurrent illness
cardiovascular event within 6 months of enrollment
seizure or seizure disorder history
contraindications to MRI- pacemakers, clips, etc

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT02064582

Recruitment Status:

Completed

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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UT Southwestern Medical Center
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT02064582

Recruitment Status:

Completed

Sponsor:


University of Texas Southwestern Medical Center

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