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NRG-GU009

Trial

Clinical Trial Title

Parallel Phase III Randomized Trials For High Risk Prostate Cancer Evaluating De-Intensification For Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation

Trial Status

Open to Enrollment

Start Date

February 17, 2021

Location

Trial Type

Cancer - Adult Oncology

Specific Condition

Prostate Cancer

Description

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding abiraterone acetate and apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

Eligibility Criteria

Eligibility Criteria

  • Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
  • High-risk disease defined as having at least one or more of the following:
  •   PSA>20 ng/mL prior to starting ADT
  •   Gleason Score of 8-10
  •   Node positive by conventional imaging with a short axis of at least 1.0 cm
  • History/physical examination within 120 days prior to registration
  • Bone imaging within 120 days prior to registration
  • Age ≥ 18
  • ECOG Performance Status of 0-2 within 120 days prior to registration

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Andrew Kee, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Friday, March 26, 2021 02:08:48 PM