OHSU Knight Cancer Institute

IRB #

STUDY00023832

Title

[NCI CIRB] NRG-GU010 (GUIDANCE) - Parallel Phase III Randomized Trials of Genomic Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation

Principal Investigator

Casey Williamson

Study Purpose

The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.
From there it will look to answer if radiation therapy alone is as effective at controlling cancer compared to the usual combination of radiation and hormone therapy in patients with unfavorable intermediate risk prostate cancer and a lot gene risk score.
Also, if 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 in patients with unfavorable intermediate risk prostate cancer and a higher gene risk score.
This study is being done to find out how these approaches are better, similar, or worse than the usual approach for prostate cancer.

Medical Condition(s)

Prostate Adenocarcinoma
Prostate Cancer
Decipher risk score / Gene risk score
Radiation
Hormone Therapy

Eligibility Criteria

Key eligibility criteria:

1. Biopsy(+) prostate adenocarcinoma within 270 days prior to registration
2. No prior hormonal therapy or pelvic radiotherapy
3. Unfavorable intermediate risk prostate cancer

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

5 years

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503-494-1080

Sponsor

NIH Natl Cancer Inst

Recruitment End

01/31/2024

Compensation Provided

No