Hormone Therapy + Radiation for Prostate Cancer

Recruiting at 12 trial locations

Overseen By Grace Pratt

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: AR inhibitors, Estrogens

Disqualifiers: Prior prostate cancer treatment, Metastatic disease, Severe heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4-16 weeks

234 Participants Needed

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.

Research Team

Martin T. King, MD, PhD

Principal Investigator

Brigham and Women's Hospital

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

My prostate cancer has a Gleason score of 7.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Darolutamide or Bicalutamide with GnRH Agonist and Radiation Therapy

4-16 weeks

Regular visits for radiation therapy administration

Follow-up

Participants are monitored for safety, effectiveness, and erectile function after treatment

3 years

Annual visits for follow-up assessments

Treatment Details

Interventions

• Bicalutamide
• Darolutamide
• GnRH Agonist
• Radiation Therapy

Trial Overview 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.

Participant Groups

Group I: Darolutamide+Radiation Therapy Experimental Treatment 2 Interventions

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

Group II: Bicalutamide+GnRH Agonist+Radiation Therapy Experimental Treatment 3 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 for the following indications:

Approved in United States as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Approved in European Union as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Approved in Canada as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Decipher Biosciences

Collaborator

Trials

2

Recruited

5,200+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

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