Purpose of this Study
We are doing this study to learn more about using Decipher risk scores to guide how we treat cancer. During the study, we will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading. This is called the Decipher risk score.
This study will use Decipher risk scores as a guide for 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. We also want to know how well an investigational drug called darolutamide (the study drug) works for people with high risk scores.
This study will use Decipher risk scores as a guide for 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. We also want to know how well an investigational drug called darolutamide (the study drug) works for people with high risk scores.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed of adenocarcinoma of the prostate and have at least one of the following "intermediate risk factors":<ul>
<li>PSA 10-20 ng/mL</li>
<li>Clinical stage T2b-c (DRE and/or imaging)</li>
<li>Gleason Score 7 (Gleason 3+4 or 4+3 [ISUP Grade Group 2-3])</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>PSA 10-20 ng/mL</li>
<li>Clinical stage T2b-c (DRE and/or imaging)</li>
<li>Gleason Score 7 (Gleason 3+4 or 4+3 [ISUP Grade Group 2-3])</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups if you are in either the low Decipher risk score or high Decipher risk score category.
If you have a low Decipher risk score, you will get a random assignment of one of these two study groups:<ul>
<li>Group 1 will get the usual radiation therapy used to treat this type of cancer. You will receive radiation therapy 2-3 days a week or 5 days a week for 2-11 weeks depending on the type of radiation therapy you receive.</li>
<li>Group 2 will get the usual radiation treatment and hormone therapy used to treat this type of cancer. You will get FDA-approved hormone therapy for 6 months, and you and your doctor will decide which hormone regimen is best for you. You will receive radiation therapy 2-3 days a week or 5 days a week for 2-11 weeks depending on the type of radiation therapy you receive.</li></ul>
If you have a high Decipher risk score, you will get a random assignment of one of these two study groups:<ul>
<li>Group 3 will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer described above for Group 2.</li>
<li>Group 4 will get the study drug plus the usual approach (hormone therapy and radiation therapy) used to treat this type of cancer. You will get the hormone and radiation therapy as described above for Group 3. In addition, you will receive the study drug as pills you take by mouth twice a day for 6 months. You will take 4 pills every day.</li></ul>
If you have a low Decipher risk score, you will get a random assignment of one of these two study groups:<ul>
<li>Group 1 will get the usual radiation therapy used to treat this type of cancer. You will receive radiation therapy 2-3 days a week or 5 days a week for 2-11 weeks depending on the type of radiation therapy you receive.</li>
<li>Group 2 will get the usual radiation treatment and hormone therapy used to treat this type of cancer. You will get FDA-approved hormone therapy for 6 months, and you and your doctor will decide which hormone regimen is best for you. You will receive radiation therapy 2-3 days a week or 5 days a week for 2-11 weeks depending on the type of radiation therapy you receive.</li></ul>
If you have a high Decipher risk score, you will get a random assignment of one of these two study groups:<ul>
<li>Group 3 will get the usual approach, hormone therapy and radiation therapy, used to treat this type of cancer described above for Group 2.</li>
<li>Group 4 will get the study drug plus the usual approach (hormone therapy and radiation therapy) used to treat this type of cancer. You will get the hormone and radiation therapy as described above for Group 3. In addition, you will receive the study drug as pills you take by mouth twice a day for 6 months. You will take 4 pills every day.</li></ul>
Study Details
Full Title
NRG-GU010: Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (GUIDANCE)
Principal Investigator
Ryan
Fecteau
Protocol Number
PRO00113621
NCT ID
NCT05050084
Phase
III
Enrollment Status
Open to Enrollment