Darolutamide + ADT for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+116 other locations

Overseen byAlicia K Morgans

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and/or prevent it from returning compared to ADT alone in patients with prostate cancer.

Eligibility Criteria

Men with high-risk prostate cancer who've had surgery (radical prostatectomy) can join this trial. They should have a good performance status, no major health issues that could affect the study, and no previous prostate cancer treatments. Their PSA levels must be undetectable and they need to meet specific criteria based on tests like Decipher score and CAPRA-S score.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I have a CAPRA-S score of 3 or higher and no lymph node involvement.

Glomerular filtration rate (GFR) >= 30 mL/min/1.73 m^2 (obtained within 4 weeks prior to registration)

+14 more

Exclusion Criteria

I have no signs of cancer spread in my body based on recent scans.

I do not have any severe illnesses or conditions that are not under control.

I have not received hormone therapy, chemotherapy, or any other systemic treatment for my prostate cancer.

+1 more

Participant Groups

The ERADICATE Study is testing if adding Darolutamide to standard hormonal therapy (ADT) after surgery is more effective than ADT alone in men with high-risk prostate cancer. It's a phase III trial aiming to see if this combination better reduces or eliminates the risk of cancer returning.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm B (ADT, darolutamide)Experimental Treatment5 Interventions

Patients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive darolutamide QID for 52 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Arm A (ADT, placebo)Active Control5 Interventions

Patients receive goserelin acetate, leuprolide acetate, or triptorelin via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive a placebo four times daily (QID) for 52 weeks in the absence of disease progression or unacceptable toxicity.