Clinical trial NCT02064582: Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer, enzalutamide, radiation, hormone therapy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2014-02-17
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
timeFrame: 12 months following initiation of treatment with enzalutamide plus GnRH agonist
Secondary outcomes:
measure: Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Kevin D Courtney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, Alyamani M, Zhang A, Chang KH, Berk M, Li Z, Zhu Z, Petro M, Magi-Galluzzi C, Taplin ME, Garcia JA, Courtney K, Klein EA, Sharifi N. Aberrant corticosteroid metabolism in tumor cells enables GR takeover in enzalutamide resistant prostate cancer. Elife. 2017 Feb 13;6:e20183. doi: 10.7554/eLife.20183.