Hormone Therapy + Radiation for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This research study is comparing the use of a new form of hormonal therapy used with radiation as a possible treatment for intermediate risk prostate cancer. More specifically, this research would help determine whether this new form of hormonal therapy is as effective as the standard hormone therapy while also preserving erectile function.
Who Is on the Research Team?
Martin T. King, MD, PhD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
Men over 18 with intermediate risk prostate cancer (T2b-T2c, Gleason 7, PSA 10-20 ng/mL) who have good erectile function and can swallow pills. They must not have had certain previous treatments for prostate cancer or other conditions that overlap with the trial's treatment areas. Participants need to agree to use contraception and should be able to undergo radiation therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Darolutamide or Bicalutamide with GnRH Agonist and Radiation Therapy
Follow-up
Participants are monitored for safety, effectiveness, and erectile function after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bicalutamide
- Darolutamide
- GnRH Agonist
- Radiation Therapy
Darolutamide is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Decipher Biosciences
Collaborator
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD