Continued Darolutamide Treatment for Cancer

Recruiting at 232 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Bayer

Must be taking: Darolutamide

Disqualifiers: Non-compliance, Negative benefit/risk, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

402 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets individuals who have taken the cancer medication darolutamide in a previous study and continue to find it beneficial. The goal is to maintain this treatment to observe its ongoing effectiveness. Participants will continue with their previous dosage and visit their doctors with the same frequency as in the earlier study. This trial suits those already benefiting from darolutamide and willing to adhere to the study requirements. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of this treatment for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing darolutamide treatment for those already on it.

Is there any evidence suggesting that darolutamide is likely to be safe for humans?

Research shows that darolutamide is generally easy for patients to tolerate. In previous studies, only 4.5% of patients with prostate cancer needed to lower their dose due to side effects, indicating most manage the treatment well. The FDA has approved darolutamide for certain types of prostate cancer, supporting its safety. Studies have shown it significantly improves survival rates compared to a placebo, indicating it is both effective and safe for widespread use. While side effects can occur, evidence suggests they are manageable for most patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for prostate cancer, which often include hormone therapies like enzalutamide or apalutamide, darolutamide stands out because of its unique mechanism of action. It targets androgen receptors with a distinct structure that results in fewer interactions with proteins in the brain, potentially leading to fewer side effects like fatigue and cognitive issues. Researchers are excited about darolutamide because it offers a promising balance of efficacy while maintaining quality of life, making it a compelling option for patients seeking effective yet tolerable treatment.

What is the effectiveness track record for darolutamide in cancer treatment?

Research has shown that darolutamide, the treatment under study in this trial, effectively treats certain types of prostate cancer. Studies have found that it significantly helps prevent cancer from worsening, as seen on scans. In one study, darolutamide lowered the risk of death by 31% compared to a placebo. Patients taking darolutamide also experienced nearly two more years without cancer spreading. Overall, the evidence supports darolutamide as an effective option for extending the time without cancer progression. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for patients who have been part of a previous Bayer-supported study on Darolutamide and are seeing benefits from its use. They must be able to consent, follow the study's rules, not have met any discontinuation criteria previously, and agree to continue using birth control.

Inclusion Criteria

I can sign and agree to follow the study's rules.

Participants who have not met any treatment discontinuation criteria in the feeder study protocol.

Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria

The investigator has determined that the possible risks of the study outweigh the potential benefits for you.

I meet the criteria to stop my current clinical trial treatment.

Participant is unable to comply with the requirements of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue treatment with darolutamide at the same dosage as in previous studies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Darolutamide

Trial Overview

The trial continues treatment with Darolutamide (Nubeqa) for cancer patients carried over from prior studies. The dosage remains the same, and participants will visit doctors as before to assess the ongoing effectiveness and safety of the drug.

How Is the Trial Designed?

Group I: Darolutamide (BAY1841788) Experimental Treatment 1 Intervention

Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.

Darolutamide is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Approved in European Union as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Approved in Canada as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer. Lee, A.[2023]

In a phase 3 trial involving 1509 men with nonmetastatic, castration-resistant prostate cancer, darolutamide significantly improved metastasis-free survival, with a median of 40.4 months compared to 18.4 months for placebo (hazard ratio 0.41).

The safety profile of darolutamide was comparable to placebo, with similar rates of adverse events and no increased risk of serious side effects like seizures or cognitive disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. Fizazi, K., Shore, N., Tammela, TL., et al.[2022]

Darolutamide is a new nonsteroidal androgen receptor inhibitor approved for treating nonmetastatic castration-resistant prostate cancer (nmCRPC), showing promise as a second-generation antiandrogen.

The drug received FDA approval in July 2019 and is currently undergoing further evaluation in the E.U., highlighting its potential as a significant treatment option for men with nmCRPC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Darolutamide for treatment of castration-resistant prostate cancer. Rhea, LP., Mendez-Marti, S., Aragon-Ching, JB.[2020]

Darolutamide, a new androgen receptor antagonist, was found to be well tolerated in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC), with most treatment-emergent adverse events being mild (Grade 1/2).

The pharmacokinetics of darolutamide showed a dose-dependent increase in drug levels, and while only 11% of patients showed a prostate-specific antigen response, the drug did not present any new safety concerns compared to Western populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 study of darolutamide (ODM-201): a new-generation androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer. Matsubara, N., Mukai, H., Hosono, A., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Darolutamide: First Approval. Markham, A., Duggan, S.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. Scott, LJ.[2022]

Citations

1.

fda.gov

fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-metastatic-castration-sensitive-prostate-cancer

FDA approves darolutamide for metastatic castration ...

Treatment with darolutamide resulted in a statistically significant improvement in rPFS compared to placebo. Median rPFS was not reached in the ...

2.

bayer.com

bayer.com/en/us/news-stories/new-data-for-nubeqa

New Data for NUBEQA® Build on Safety and Efficacy ...

NUBEQA (darolutamide) plus androgen deprivation therapy (ADT) improved radiological progression-free survival (rPFS) by 40% (HR 0.60; 95% CI: 0.44-0.80) and 70 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37660438/

Efficacy and safety outcomes of darolutamide in patients ...

Darolutamide significantly improved median metastasis-free survival by nearly 2 years and reduced the risk of death by 31% versus placebo, with a favourable ...

4.

nubeqa-us.com

nubeqa-us.com/about-nubeqa/mcspc-study-results

Clinical Study | NUBEQA® (darolutamide) | Patient Website

At the time of analysis, 29% (128 out of 446) of men taking NUBEQA + ADT had cancer worsening via scans or were no longer living compared to 42% (94 out of 223) ...

5.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e17108

Real world outcomes of darolutamide efficacy and safety in ...

Adverse events led to dose reductions in 4.5% (n=6) of nmHSPC and 1.8% (n=1) of mHSPC patients. Surgical data for 51.1% (n=68) of nmHSPC ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02200614

NCT02200614 | Efficacy and Safety Study of Darolutamide ...

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.