Hormone Therapy + Radiation for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen byMartin T. King, MD, PhD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

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.

Eligibility Criteria

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

My prostate cancer is at an intermediate stage, with specific test results.

PSA 10-20 ng/mL

I am 18 years old or older.

+33 more

Exclusion Criteria

I have been treated with specific prostate cancer drugs for more than 28 days.

Any condition that, in the opinion of the site investigator, would preclude participation in this study

I have undergone orchiectomy or been on hormonal therapy for cancer.

+17 more

Participant Groups

The study is testing a new hormonal therapy combined with radiation against standard hormone therapy in treating intermediate risk prostate cancer. The goal is to see if the new therapy works as well while better preserving erectile function.

2Treatment groups

Experimental Treatment

Group I: Darolutamide+Radiation TherapyExperimental Treatment2 Interventions

* Darolutamide is administered orally twice daily * Radiation therapy is administered starting 4-16 weeks after Darolutamide

Group II: Bicalutamide+GnRH Agonist+Radiation TherapyExperimental Treatment3 Interventions

* Bicalutamide is administered orally on a daily basis * GnRH Agonist as prescribed * Radiation therapy is administered starting 4-16 weeks after ADT

Darolutamide is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Nubeqa for: