Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT02064582
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 7
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enzalutamide, Leuprolide, radiation Leuprolide acetate Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care Enzalutamide, Leuprolide, radiation radiation Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care Enzalutamide, Leuprolide, radiation Enzalutamide Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
- Primary Outcome Measures
Name Time Method 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 12 months following initiation of treatment with enzalutamide plus GnRH agonist Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0
- Secondary Outcome Measures
Name Time Method Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy 12 months Fold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy.
Trial Locations
- Locations (1)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States