Darolutamide + ADT for Metastatic Hormone-Sensitive Prostate Cancer

(ARASEC Trial)

Not currently recruiting at 56 trial locations

Overseen By Bayer Clinical Trials Contact

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Bayer

Must be taking: ADT

Must not be taking: Relugolix, 5-alpha reductase inhibitors

Disqualifiers: Recent malignancy, Cardiac events, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding darolutamide (a medication for prostate cancer) to standard hormone treatment (ADT, also known as Androgen Suppression Therapy) can better control prostate cancer that has spread. Researchers aim to determine if this combination prolongs the period before the cancer worsens. Participants will continue both treatments until their cancer progresses or they experience other health issues. Men with metastatic prostate cancer who have already begun hormone therapy might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but certain medications like relugolix and 5-alpha reductase inhibitors must not be used. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that darolutamide, when combined with androgen deprivation therapy (ADT), is generally well-tolerated by patients with metastatic prostate cancer. Studies have found this combination to be both effective and safe, with positive results in extending the time patients live without cancer progression.

Darolutamide is already approved for treating non-metastatic prostate cancer, indicating its safety. In earlier studies, patients taking darolutamide with ADT experienced some side effects, which were usually manageable. The most common side effect was fatigue, along with some mild side effects. Serious side effects occurred less frequently.

Overall, these findings support the safety of using darolutamide with ADT for prostate cancer. Participating in a clinical trial can provide more insights into its effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for prostate cancer?

Researchers are excited about darolutamide for metastatic hormone-sensitive prostate cancer because it offers a fresh approach compared to standard treatments like androgen deprivation therapy (ADT) alone. Darolutamide is unique because it specifically targets and inhibits the action of male hormones that fuel prostate cancer growth, potentially providing a more effective blockade with fewer side effects due to its limited penetration into the brain. This distinct mechanism, combined with its promising ability to enhance the effects of ADT, makes darolutamide a hopeful advancement in treating this type of cancer.

What evidence suggests that darolutamide plus ADT might be an effective treatment for metastatic hormone-sensitive prostate cancer?

In this trial, participants will receive a combination of darolutamide and hormone therapy (ADT) to treat metastatic hormone-sensitive prostate cancer. Research has shown that adding darolutamide to hormone therapy holds promise for treating prostate cancer that has spread and still responds to hormones. Studies have found that this combination significantly delays cancer progression. Darolutamide stops cancer cells from using male hormones, which helps slow the cancer's growth. Early results indicate that this treatment combination reduces the risk of the cancer spreading or worsening compared to hormone therapy alone. Overall, darolutamide with hormone therapy could offer better control over the cancer's progression. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

Men with metastatic hormone-sensitive prostate cancer who have started ADT up to 120 days before joining. They must have good organ function, no severe recent surgeries, and an ECOG Performance Status of 0-2. Excluded are those with certain other cancers in the last 5 years, brain metastases, uncontrolled hypertension, or previous treatments that could interfere.

Inclusion Criteria

I have taken medication to prevent flare before starting hormone therapy.

It's been over 4 weeks since my last major surgery and I've recovered from it.

I've had hormone therapy before surgery or alongside other treatments, meeting all required conditions.

Exclusion Criteria

I have not had cancer in the last 5 years, except for skin cancer.

My high blood pressure is not under control.

I have cancer that has spread to my brain or its coverings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive darolutamide plus ADT until cancer progression, medical problem, or withdrawal

Approximately 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term Follow-up

Participants are monitored for overall survival and radiographic progression-free survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• ADT
• Darolutamide

Trial Overview The trial is testing if adding darolutamide to standard ADT improves progression-free survival compared to ADT alone in men with mHSPC. Progression-free survival means how long patients live without their cancer getting worse.

How Is the Trial Designed?

Group I: Darolutamide+ADT Experimental Treatment 2 Interventions

Participants will receive darolutamide plus ADT in the ARASEC treatment arm. The control arm for the study will be derived from the participants treated with ADT alone in the CHAARTED trial using a matching approach

ADT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in United States as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in Canada as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in Japan as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in China as Androgen Deprivation Therapy for:

• Prostate Cancer

Approved in Switzerland as Androgen Deprivation Therapy for:

• Prostate Cancer

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 (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 a phase 3 trial with 1306 patients suffering from metastatic, hormone-sensitive prostate cancer, the addition of darolutamide to standard treatment significantly reduced the risk of death by 32.5% compared to placebo, indicating its efficacy in improving overall survival.

The safety profile of darolutamide was comparable to placebo, with similar rates of adverse events, suggesting that it can be safely combined with androgen-deprivation therapy and docetaxel without increasing the risk of severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. Smith, MR., Hussain, M., Saad, F., et al.[2023]

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]

Darolutamide is an FDA-approved nonsteroidal androgen inhibitor specifically for treating castration-resistant non-metastatic prostate cancer, providing a new option for patients whose PSA levels are rising despite low testosterone.

When used alongside androgen deprivation therapy (ADT), darolutamide, like other newer agents in its class, has been shown to prolong metastasis-free survival and median survival, making it an effective treatment choice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using darolutamide in advanced prostate cancer: How I Do It. Hamilton, J.[2021]

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]

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]

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]

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39279580/

Darolutamide in Combination With Androgen-Deprivation ... At the primary cutoff date (June 7, 2024), darolutamide plus ADT significantly improved rPFS, reducing the risk of radiological progression or ...

3. bayer2019tf.q4web.com bayer2019tf.q4web.com/news/news-details/2025/New-Data-for-NUBEQA-Build-on-Safety-and-Efficacy-Results-Across-Subgroups-of-Patients-with-Metastatic-Hormone-Sensitive-Prostate-Cancer/default.aspx

New Data for NUBEQA® Build on Safety and Efficacy Results ... New subgroup data from the investigational Phase III ARANOTE trial show NUBEQA (darolutamide) plus androgen-deprivation therapy (ADT) improved radiological ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.89

Prospective real world data evaluation of clinical outcomes ... Efficacy outcomes 12 months after initiation of darolutamide in non-metastatic castrate resistant prostate cancer (nmCRPC) from the real world ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2119115

Darolutamide and Survival in Metastatic, Hormone ... Darolutamide is a potent androgen-receptor inhibitor that has been associated with increased overall survival among patients with nonmetastatic, castration- ...

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

Real world outcomes of darolutamide efficacy and safety in ... Our real-world data demonstrates the effectiveness and safety of darolutamide in patients with nmHSPC or mHSPC.

7. 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 ...

8. nubeqahcp.com nubeqahcp.com/efficacy/mcspc

mCSPC Efficacy | NUBEQA® (darolutamide) | HCP Explore efficacy, study design, and adverse reactions from the ARASENS and ARANOTE trials of NUBEQA® (darolutamide) in mCSPC. See safety and full ...