Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk 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:||April 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02023463
|Contact: Robert Den, MD||Robert.Den@jeffersonhospital.org|
|Contact: Radiation Oncology Protocol Office||215-955-8619|
|United States, Pennsylvania|
|Thomas Jefferson University||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: 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|
|Sub-Investigator: Perry Weiner, MD|
|Principal Investigator:||Robert Den, MD||Thomas Jefferson University|