Study on Adding Darolutamide to Hormonal Therapy After Surgery for Men with High-Risk Prostate Cancer
Sponsor: ECOG-ACRIN Cancer Research Group
ClinicalTrials ID:NCT04484818
This clinical trial is exploring whether adding the drug darolutamide to standard hormonal therapy after surgery can better treat high-risk prostate cancer by reducing or eliminating the cancer and preventing it from coming back.
Patient Parameters
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Program Overview
This study is testing if adding darolutamide to standard hormonal therapy (ADT) after surgery can improve treatment outcomes for men with high-risk prostate cancer. ADT works by lowering testosterone levels, which can help slow the growth of prostate cancer. Darolutamide blocks the effects of testosterone in cancer cells. The study aims to see if this combination is more effective than ADT alone in reducing cancer size and preventing its return.
Description
The main goal of this study is to find out if 12 months of hormonal therapy (ADT) combined with darolutamide can help men with high-risk prostate cancer live longer without the cancer spreading, compared to ADT with a placebo. The study will also look at whether this combination improves the time until cancer returns, overall survival, and how quickly testosterone levels recover after treatment. Researchers will also evaluate the safety of the treatment and its impact on quality of life, including fatigue and cognitive function.
Participants will be randomly assigned to one of two groups. One group will receive standard hormonal therapy (ADT) and a placebo, while the other group will receive ADT and darolutamide. Both treatments will last for 12 months. After completing the treatment, participants will have follow-up visits every three months for three years to monitor their health and any changes in their cancer status.
Eligibility Criteria
Inclusion Criteria
- Must have had surgery to remove the prostate (radical prostatectomy) 6 to 16 weeks before joining the study.
- Must be in good general health with an ECOG performance status of 0 to 2.
- Can have other cancers if they do not interfere with this study.
- HIV-positive patients can join if their viral load is undetectable.
- Patients with hepatitis B or C can join if their viral load is undetectable or they are cured.
- Must provide a tumor sample from surgery if no previous Decipher score is available.
- Must have a Decipher score of 0.6 or higher if previously tested.
- Must have a CAPRA-S score of 3 or higher if no previous Decipher score.
- Must have undetectable PSA levels before randomization.
- Must meet specific blood count and organ function criteria.
Exclusion Criteria
- Must not have had any previous hormonal therapy, chemotherapy, or other systemic treatments for prostate cancer.
- Must not have cancer spread to pelvic lymph nodes.
- Must not have serious health conditions that could interfere with the study.
- Must not have signs of cancer recurrence or spread on imaging tests before randomization.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Los Angeles County-USC Medical Center | 90033 | Los Angeles | California |
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| Stanford Cancer Institute Palo Alto | 94304 | Palo Alto | California |
| VA Palo Alto Health Care System | 94304 | Palo Alto | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| City of Hope Upland | 91786 | Upland | California |
| Hartford Hospital | 06102 | Hartford | Connecticut |
| GenesisCare USA - Lakewood Ranch | 34202 | Lakewood Rch | Florida |
| Mount Sinai Medical Center | 33140 | Miami Beach | Florida |
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