Enzalutamide + External Beam Rt For Prostate
Enzalutamide With External Beam Radiation for Intermediate Risk Prostate Cancer: A Phase II Study
Sponsor study identifier
interventional
64
1 country
3
Study Start
February 2014
Actual (reported)Primary Completion
October 2017
Actual (reported)Study Completion
January 2018
Actual (reported)This research study is evaluating a drug called enzalutamide in combination with external beam radiation therapy as a possible treatment for prostate cancer. Presently, when participants receive hormonal therapy with radiation therapy for prostate cancer, medications are given to reduce testosterone levels in the blood stream. This leads to side effects such as loss of sex drive, erectile dysfunction (ED) and decrease in muscle strength. The purpose of this study is test another form of hormonal therapy with radiation therapy. The medication called enzalutamide will be used with radiation therapy. Instead of lowering testosterone, enzalutamide blocks testosterone in cells. This study will test if enzalutamide when used with radiation will lower the PSA without causing the side effects associated with medications that lower testosterone in the blood stream.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 16, 2013
Actual (reported)January 7, 2014
Actual (reported)February 2014
Actual (reported)October 2017
Actual (reported)January 2018
Actual (reported)May 6, 2023
Actual (reported)Percentage of Participants With PSA at or Below 0.2 ng/ml
Percentage of participants with PSA level of less than or equal to 0.2 ng/ml at the end of six cycles of enzalutamide and EBRT treatment. Post-treatment PSA nadir level has been shown to be a validated intermediate cancer endpoint in similar settings. The chosen cut-off of 0.2 ng/ml was informed by D'Amico et al Lancet Oncology 2012. PSA levels determined through established methods (blood draw and serum analysis).
End of treatment, up to 27 weeks.
Median DHEA-S
Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Median Androstenedione
Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Median Testosterone
Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Median Free Testosterone
Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Median Estrone
Assessed cycle 1, cycle 5, and end of treatment, up to 27 weeks
Enzalutamide 40 mg orally 4x daily for 6 (28 day +/-3 days) cycles. External Beam Radiation Therapy (EBRT) - 7-10 weeks after beginning Enzalutamide 75.6 to 79.2 Gy in 1.8 Gy fractions for up to 11 weeks. \*Patients that are unable to complete enzalutamide therapy will still be treated with EBRT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Kaplan I, Bubley GJ, Bhatt RS, Taplin ME, Dowling S, Mahoney K, Werner E, Nguyen P. Enzalutamide With Radiation Therapy for Intermediate-Risk Prostate Cancer: A Phase 2 Study. Int J Radiat Oncol Biol Phys. 2021 Aug 1;110(5):1416-1422. doi: 10.1016/j.ijrobp.2021.02.027. Epub 2021 Feb 23.
Glenn Bubley, MD
Beth Israel Deaconess Medical Center
64 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2013
First Posted
January 7, 2014
Study Start
February 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 2017
Actual (reported)Study Completion
January 2018
Actual (reported)Last Updated
May 6, 2023
Results First Posted
May 6, 2023
Record last verified: 2023-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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