• Home
  • Study Details
Open

NRG-GU010 GUIDANCE

This study is being done to answer the following questions: If you have unfavorable intermediate risk prostate cancer, a low gene risk score and plan to receive radiation therapy with hormone therapy, is radiation therapy alone as effective at controlling your cancer compared to the usual combination of radiation and hormone therapy? If you have unfavorable intermediate risk prostate cancer, a higher gene risk score and plan to receive radiation therapy with hormone therapy, does adding another new hormone therapy drug to the usual combination of radiation and hormone therapy increase the length of time without your prostate cancer spreading as compared to the usual treatment? We are doing this study because we want to find out how these approaches are better, similar, or worse than the usual approach for your type of prostate cancer. The usual treatment is defined as the care most people get for prostate cancer.

Age & Gender

  • 18 years ~ 99 years
  • Male, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)
  • Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

You will be asked to come to the hospital for blood draws, clinic assement with your provider, imaging, complete study questionnaires, and treatment.

Incentives

Darolutamide (BAY 1841788) Bayer AG is providing the study drug

In-person visits:
12-15
Total length of participation:
Depending on treatment group treatment will occur up to 12 months. After treatment, follow up will occur quarterly and then annually for the remainder of

Looking for Specific Volunteers

Able to participate:

  • Patients with prostate cancer
  • Patients with adequate kidney, liver, and bone marrow function

Not eligible if:

  • Patients who have had previous radical surgery for prostate cancer.
  • Patients whose prostate cancer has spread to other areas (metastatic disease)
  • Patients on testosterone replacement therapy (TRT) must stop TRT prior to study participation
  • Patients unable to swallow pills

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Michael Repka
Radiation Oncology - Chapel Hill

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Prostate)

IRB Number

23-1081

ClinicalTrials.gov

NCT05050084

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research