Darolutamide for Prostate Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Prostate Cancer+1 More
Darolutamide - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing if adding darolutamide to ADT (a treatment to reduce testosterone levels) is more effective than ADT alone in treating high-risk prostate cancer.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: From randomization to any of the MFS events, pelvic lymph node recurrence or detectable prostate-specific antigen (PSA) (PSA >= 0.2 ng/mL, confirmed by a second PSA of the same level or higher), whichever occurs first, assessed up to 36 months

Month 12
Cognitive function
At 18 months
Overall quality of life: Functional Assessment of Cancer Therapy (FACT)
Month 36
Testosterone recovery rate
Month 12
Change in cognitive function
Month 18
Change in Functional Assessment of Cancer Therapy (FACT) - Prostate score
Change in quality of life: Functional Assessment of Cancer Therapy (FACT)
Month 36
Time to testosterone recovery
Month 36
Recurrence-free survival (RFS)
Month 36
Event-free survival
Month 36
Overall survival
Month 36
Metastasis-free survival (MFS)
Up to 36 months
Decipher scores
Genome-wide alterations
Identification of novel gene expression signatures
Prognostic value of established signatures
Up to 78 weeks
Incidence of adverse events

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Arm A (ADT, placebo)
1 of 2
Arm B (ADT, darolutamide)
1 of 2

Active Control

Experimental Treatment

810 Total Participants · 2 Treatment Groups

Primary Treatment: Darolutamide · Has Placebo Group · Phase 3

Arm B (ADT, darolutamide)Experimental Group · 5 Interventions: Triptorelin, Darolutamide, Goserelin Acetate, Quality-of-Life Assessment, Leuprolide Acetate · Intervention Types: Drug, Drug, Drug, Other, Drug
Arm A (ADT, placebo)ActiveComparator Group · 5 Interventions: Triptorelin, Goserelin Acetate, Quality-of-Life Assessment, Leuprolide Acetate, Placebo Administration · Intervention Types: Drug, Drug, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Triptorelin
FDA approved
Darolutamide
FDA approved
Goserelin
FDA approved
Lidocaine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to any of the mfs events, pelvic lymph node recurrence or detectable prostate-specific antigen (psa) (psa >= 0.2 ng/ml, confirmed by a second psa of the same level or higher), whichever occurs first, assessed up to 36 months

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
103 Previous Clinical Trials
171,225 Total Patients Enrolled
4 Trials studying Prostate Cancer
1,895 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,000 Previous Clinical Trials
41,300,097 Total Patients Enrolled
533 Trials studying Prostate Cancer
501,523 Patients Enrolled for Prostate Cancer
Alicia K MorgansPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of hepatitis C virus (HCV) infection and are currently on treatment.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2.
You are HIV-positive and on effective anti-retroviral therapy with undetectable viral load within 6 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.