Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
This phase I trial studies the side effects and best way to give enzalutamide, radiation therapy, and hormone therapy in treating patients with intermediate or high-risk prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as enzalutamide, may lessen the amount of androgens made by the body. Radiation therapy uses high energy x rays to kill tumor cells. Giving enzalutamide, radiation therapy, and hormone therapy may be an effective treatment for prostate cancer.
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Drug: Goserelin acetate
Drug: Leuprolide acetate
Radiation: Radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase Ib Trial of Enzalutamide in Combination With Radiation Therapy and LHRH Agonist Therapy in the Management of Intermediate and High-Risk Prostate Cancer|
- Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria [ Time Frame: Up to 1 month post completion of enzalutamide ] [ Designated as safety issue: Yes ]An exact 2-sided binomial 90% confidence interval will be computed and reported. Toxicity will be monitored and if there is greater than 10% incidence of grade 3 or higher gastrointestinal (GI)/genitourinary (GU)/fatigue lasting more than 7 days despite optimal treatment, the trial will be re-evaluated.
- Change in PSA levels [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]Evaluated using linear mixed models. Mixed models will make use of all available data, and can estimate individual levels of change.
- Quality of life (QoL), measured using the EPIC, AUA symptom index, and the PROMIS Fatigue Scale [ Time Frame: Baseline up to 1 year ] [ Designated as safety issue: No ]QoL measures will also be assessed via linear mixed models, as an exploratory evaluation of potential clinical correlates, such as age, race, stage, Gleason score, etc.
|Study Start Date:||March 2014|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Experimental: Treatment (enzalutamide, radiation therapy, hormone therapy)
Patients receive enzalutamide PO QD for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate SC or leuprolide acetate IM or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH therapy, patients undergo either IMRT or VMAT daily five days a week for 8 weeks.
Other Names:Drug: Goserelin acetate
Other Names:Drug: Leuprolide acetate
Given IM or SC
Other Names:Radiation: Radiation therapy
Undergo image-guided radiation therapy
1) To assess the safety of the combination of neoadjuvant and concurrent enzalutamide with an luteinizing-hormone-releasing hormone (LHRH) agonist and radiation therapy.
- To determine the efficacy of the combination of enzalutamide with an LHRH agonist and radiation therapy using prostate specific antigen (PSA) kinetics.
- To determine the efficacy of the combination of enzalutamide with an LHRH agonist and radiation therapy using PSA nadir.
- To describe patient-reported outcomes including: Expanded Prostate Cancer Index Composite (EPIC), American Urological Association (AUA) Symptom Index, PROstate magnetic resonance (MR) Imaging Study (PROMIS) Fatigue Scale.
Patients receive enzalutamide orally (PO) once daily (QD) for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate subcutaneously (SC) or leuprolide acetate intramuscularly (IM) or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH agonist therapy, patients undergo either intensity modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) daily five days a week for 8 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
|Contact: Robert Den, MDemail@example.com|
|Contact: Radiation Oncology Protocol Office||215-955-8619|
|United States, Pennsylvania|
|Thomas Jefferson University||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Robert Den, MD|
|Contact: Radiation Oncology Protocol Office 215-955-8619|
|Principal Investigator: Robert Den, MD|
|Sub-Investigator: Leonard Gomella, MD|
|Sub-Investigator: Karen Knudsen, PhD|
|Sub-Investigator: William Kevin Kelly, DO|
|Sub-Investigator: Costas Lallas, MD|
|Sub-Investigator: Edouard Trabulsi, MD|
|Sub-Investigator: Jianqing Lin, MD|
|Sub-Investigator: Jean Hoffman-Censits, MD|
|Sub-Investigator: Adam Dicker, MD, PhD|
|Sub-Investigator: Mark Hurwitz, MD|
|Sub-Investigator: Ruth Birbe, MD|
|Sub-Investigator: Peter McCue, MD|
|Principal Investigator:||Robert Den, MD||Thomas Jefferson University|