Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
NCT ID: NCT02064582
Last Updated: 2020-10-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
7 participants
INTERVENTIONAL
2014-05-31
2018-06-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer
NCT02023463
Enzalutamide + External Beam Rt For Prostate
NCT02028988
Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate
NCT02268175
Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer
NCT02508636
Relugolix + Enzalutamide Study in High-Risk Prostate Cancer
NCT06130995
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enzalutamide, Leuprolide, 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
160mg by mouth each day
Leuprolide acetate
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation
External beam radiation will be delivered as per standard radiation therapy protocol
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enzalutamide
160mg by mouth each day
Leuprolide acetate
22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation
External beam radiation will be delivered as per standard radiation therapy protocol
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
90 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astellas Pharma US, Inc.
INDUSTRY
University of Texas Southwestern Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kevin Dale Courtney
Associate Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kevin D Courtney, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STU 082013-032
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.