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Darolutamide+ADT for Prostate Cancer

City of Hope National Medical Center, Duarte, CA
Prostate CancerDarolutamide (BAY1841788, Nubeqa) - Drug
Eligibility
18+
Male
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Study Summary

This trial is researching if a combination of ADT and darolutamide can help men with prostate cancer at high risk of biochemical recurrence (BCR) live longer without their cancer getting worse.

Eligible Conditions
  • Biochemically Recurrent Prostate Cancer

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

1
Lead-in phase: Darolutamide treatment
1
Treatment (MRI-guided IMRT, ADT)
2
Quality-of-Life Assessment

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: After randomization to after last treatment, approximately 46 months

Month 24
Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
Time to deterioration in the Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score
Month 46
Metastasis-free survival (MFS) by Conventional imaging (CI) assessed by BICR
Overall survival (OS)
Prostate-specific antigen (PSA) undetectable rates (<0.2 ng/mL)
Time to Castration-resistant prostate cancer (CRPC) assessed by investigator
Time to first Symptomatic skeletal event (SSE)
Time to initiation of first subsequent systemic antineoplastic therapy
Time to loco-regional progression by PSMA PET/CT
Month 25
Number of participants who discontinue study treatment due to a TEAE
Number of participants with Treatment-emergent adverse events (TEAEs) and Treatment-emergent serious adverse events (TESAEs) categorized by severity

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Lead-in phase: Darolutamide treatment
2
Treatment (MRI-guided IMRT, ADT)
3
Quality-of-Life Assessment

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Darolutamide+ADT
1 of 2
Placebo+ADT
1 of 2

Experimental Treatment

Non-Treatment Group

750 Total Participants · 2 Treatment Groups

Primary Treatment: Darolutamide+ADT · Has Placebo Group · Phase 3

Darolutamide+ADTExperimental Group · 2 Interventions: Darolutamide (BAY1841788, Nubeqa), ADT · Intervention Types: Drug, Other
Placebo+ADTPlaceboComparator Group · 2 Interventions: Placebo matching darolutamide, ADT · Intervention Types: Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: after randomization to after last treatment, approximately 46 months

Who is running the clinical trial?

BayerLead Sponsor
2,173 Previous Clinical Trials
24,086,825 Total Patients Enrolled
37 Trials studying Prostate Cancer
25,436 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

Are there opportunities to participate in this medical experiment?

"It appears that this clinical trial has already filled its quota of patients, as the listing was last updated on March 21st 2023. Nonetheless, there are 1239 other trials currently recruiting participants at this time." - Anonymous Online Contributor

Unverified Answer

Has the Darolutamide+ADT drug combination been given clearance by the FDA?

"The safety of Darolutamide+ADT was rated a 3 due to the existence of evidence-backed efficacy and multiple rounds of research proving its safety." - Anonymous Online Contributor

Unverified Answer

In what areas of the country is this clinical trial accessible?

"This trial is currently being administered at 184 different medical facilities. These include Tucson, Duarte and Los Angeles, among other urban centres. Potential participants should consider choosing the clinic that's closest to them in order to limit their time spent commuting." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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