27 Participants Needed

Darolutamide + ADT for Prostate Cancer

Recruiting at 116 trial locations
Age: 18+
Sex: Male
Trial Phase: Phase 3
Sponsor: ECOG-ACRIN Cancer Research Group
Must be taking: ADT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not have had any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other systemic therapy for prostate cancer.

Is darolutamide safe for humans?

Darolutamide, used with androgen deprivation therapy (ADT), has been generally well tolerated in clinical trials for prostate cancer, with a low chance of causing central nervous system-related side effects compared to similar treatments. Its safety profile is considered manageable, and adverse events are consistent with those of other treatments like ADT and docetaxel.12345

How does the drug Darolutamide + ADT differ from other prostate cancer treatments?

Darolutamide is unique because it is a non-steroidal androgen receptor antagonist that has minimal penetration into the brain, reducing the risk of central nervous system side effects compared to other similar drugs. It is used in combination with androgen deprivation therapy (ADT) and has shown effectiveness in prolonging survival in both non-metastatic and metastatic prostate cancer, offering a new option for patients with high-risk or advanced disease.12367

What data supports the effectiveness of the drug Darolutamide + ADT for prostate cancer?

Darolutamide, when combined with androgen deprivation therapy (ADT), has been shown to significantly prolong survival in men with both non-metastatic and metastatic prostate cancer, according to clinical trials. It is generally well tolerated and offers an important treatment option for patients at high risk of cancer spreading.12356

Who Is on the Research Team?

AK

Alicia K Morgans

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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)
See 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.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ADT and either darolutamide or placebo for 12 months

52 weeks
Injections every 1, 3, or 4 months; daily oral administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months
Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Darolutamide
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (ADT, darolutamide)Experimental Treatment5 Interventions
Group II: Arm A (ADT, placebo)Active Control5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials
122
Recruited
160,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In the phase 3 ARAMIS trial, darolutamide significantly improved metastasis-free survival and overall survival in men with non-metastatic castration-resistant prostate cancer compared to placebo, indicating its efficacy when combined with ongoing androgen deprivation therapy.
Darolutamide was generally well tolerated, showing a low risk of central nervous system-related side effects, which is a common concern with other second-generation androgen receptor inhibitors.
Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer.Scott, LJ.[2022]
Darolutamide (NUBEQA™) is a new non-steroidal androgen receptor antagonist approved for treating non-metastatic castration-resistant prostate cancer in men, based on positive results from the phase III ARAMIS trial.
The approval of darolutamide marks a significant milestone in prostate cancer treatment, highlighting its efficacy and safety profile as demonstrated in clinical trials.
Darolutamide: First Approval.Markham, A., Duggan, S.[2020]
Darolutamide, an oral androgen receptor inhibitor, significantly improves overall survival in patients with metastatic hormone-sensitive prostate cancer when combined with androgen deprivation therapy and docetaxel, compared to placebo.
The treatment with darolutamide has a manageable safety profile, with adverse events aligning with those typically seen in androgen deprivation therapy and docetaxel, making it a viable option for patients with high-volume disease.
Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer.Lee, A.[2023]

Citations

Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. [2022]
Darolutamide: First Approval. [2020]
Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer. [2023]
Phase 1 study of darolutamide (ODM-201): a new-generation androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer. [2023]
Using darolutamide in advanced prostate cancer: How I Do It. [2021]
Darolutamide for treatment of castration-resistant prostate cancer. [2020]
Darolutamide (ODM-201) for the treatment of prostate cancer. [2018]
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