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

Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Enzalutamide (Drug); Leuprolide acetate (Drug); radiation (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Kevin D Courtney, MD, PhD, Principal Investigator, Affiliation: UT Southwestern Medical Center

Overall contact:
Allison Beaver, RN, BSN, Phone: 214-645-8787, Email: Allison.Beaver@utsouthwestern.edu

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assess the safety and tolerability of combining enzalutamide with a GnRH and external beam radiation

Secondary outcome: Assess intra-tumoral androgen regulated gene expression pre and post combination therapy

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Male.

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

Locations and Contacts

Allison Beaver, RN, BSN, Phone: 214-645-8787, Email: Allison.Beaver@utsouthwestern.edu

UT Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Allison Beaver, RN, BSN, Phone: 214-645-8787, Email: Allison.Beaver@utsouthwestern.edu
Kevin D Courtney, MD, Principal Investigator
Additional Information

Starting date: May 2014
Last updated: May 5, 2015

Page last updated: August 23, 2015

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