Darolutamide for Prostate Cancer

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

Study Summary

This trial will test if adding darolutamide to ADT with a LHRHA can help prevent prostate cancer from coming back in men at very high risk of recurrence after radiation therapy.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Through study completion, an average of 5 years

Year 2
Frequency and severity of adverse events (CTCAE v5.0, RTOG/EORTC acute/late radiation morbidity criteria)
Year 5
Fear of cancer recurrence
Health-related quality of life
Metastasis-free survival
Overall survival
PSA-progression free survival
Malignant Neoplasms
Time to castration-resistance
Time to subsequent hormonal therapy

Trial Safety

Safety Progress

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

Trial Design

2 Treatment Groups

Darolutamide
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

1100 Total Participants · 2 Treatment Groups

Primary Treatment: Darolutamide · Has Placebo Group · Phase 3

DarolutamideExperimental Group · 3 Interventions: Darolutamide, External Beam Radiotherapy, Luteinizing Hormone-Releasing Hormone Analog · Intervention Types: Drug, Radiation, Drug
PlaceboPlaceboComparator Group · 3 Interventions: External Beam Radiotherapy, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog · Intervention Types: Radiation, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Darolutamide
FDA approved
External Beam Radiotherapy
1995
Completed Phase 3
~440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 5 years

Who is running the clinical trial?

University of SydneyLead Sponsor
170 Previous Clinical Trials
198,381 Total Patients Enrolled
4 Trials studying Prostate Cancer
488 Patients Enrolled for Prostate Cancer
Australian and New Zealand Urogenital and Prostate Cancer Trials GroupOTHER
18 Previous Clinical Trials
5,507 Total Patients Enrolled
3 Trials studying Prostate Cancer
644 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,150 Previous Clinical Trials
23,873,943 Total Patients Enrolled
35 Trials studying Prostate Cancer
24,062 Patients Enrolled for Prostate Cancer
Cancer Trials IrelandNETWORK
78 Previous Clinical Trials
22,413 Total Patients Enrolled
7 Trials studying Prostate Cancer
1,082 Patients Enrolled for Prostate Cancer
Canadian Cancer Trials GroupNETWORK
114 Previous Clinical Trials
64,923 Total Patients Enrolled
9 Trials studying Prostate Cancer
5,725 Patients Enrolled for Prostate Cancer
Prostate Cancer Clinical Trials ConsortiumOTHER
10 Previous Clinical Trials
6,128 Total Patients Enrolled
7 Trials studying Prostate Cancer
5,934 Patients Enrolled for Prostate Cancer
Memorial Sloan Kettering Cancer CenterOTHER
1,832 Previous Clinical Trials
583,317 Total Patients Enrolled
127 Trials studying Prostate Cancer
64,315 Patients Enrolled for Prostate Cancer
Tamim NiaziStudy ChairJewish General Hospital and McGill University
Christopher SweeneyStudy ChairDana-Farber Cancer Institute and Harvard Medical School
1 Previous Clinical Trials
1,125 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing to complete HRQL questionnaires unless you are unable to complete due to literacy or limited vision.
You have a pathological diagnosis of adenocarcinoma of the prostate.
You have adequate renal function.
You have a performance status of 0 or 1.
You are able to start treatment within 7 days after randomisation.

Who else is applying?

What site did they apply to?
BC Cancer Agency (BCCA) Fraser Valley100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%