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



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 90
Updated:5/17/2018
Start Date:May 2014
End Date:April 2019

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Phase 2 Study of Enzalutamide and GnRH Agonist Before, During and After Radiation Therapy in Treatment of Patients With High-risk Localized Prostate Cancer

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.

- 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

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
We found this trial at
1
site
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Kevin D Courtney, MD
Phone: 214-645-8787
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Dallas, TX
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