Clinical Trials/NCT04736199

NCT04736199

Active, not recruiting

Phase 3

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Bayer191 sites in 10 countries669 target enrollmentFebruary 23, 2021

ConditionsProstatic Neoplasms

InterventionsDarolutamide (Nubeqa, BAY1841788)Androgen deprivation therapy (ADT)Placebo

DrugsDarolutamide (Nubeqa, BAY1841788)Placebo

Overview

Phase: Phase 3
Intervention: Darolutamide (Nubeqa, BAY1841788)
Conditions: Prostatic Neoplasms
Sponsor: Bayer
Enrollment: 669
Locations: 191
Primary Endpoint: Radiological Progression-free Survival (rPFS) Assessed by Central Review
Status: Active, not recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

The purpose of the study is to assess the efficacy and safety of darolutamide in combination with standard androgen deprivation therapy (ADT) in patients with metastatic hormone sensitive prostate cancer.

Registry

clinicaltrials.gov

Start Date

February 23, 2021

End Date

January 30, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed adenocarcinoma of prostate
•Metastatic disease
•Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but not earlier than 12 weeks before randomization
•Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2
•Adequate bone marrow, liver and renal function

Exclusion Criteria

•Prior treatment with: LHRH agonist/antagonists except neoadjuvant and /or adjuvant therapy; Second-generation androgen receptor (AR) inhibitors such as enzalutamide, darolutamide, apalutamide or other investigational AR inhibitors; Cytochrome P17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as anti-cancer treatment for prostate cancer; Chemotherapy including docetaxel or immunotherapy for prostate cancer; Use of systemic corticosteroid with dose greater than the equivalent 10 mg of prednisone/day within 28 days prior to randomization; Radiopharmaceuticals; Any other anti-cancer treatment for prostate cancer, excluding local therapies and ADT.
•Treatment with radiotherapy within 2 weeks before randomization
•Contraindication to iodinated CT and gadolinium chelate MRI intravenous contrast agent(s)
•Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association Class III or IV)
•Uncontrolled hypertension as indicated by a resting systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite medical management
•A gastrointestinal (GI) disorder or procedure which is expected to interfere significantly with absorption of study drug
•Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
•Inability to swallow oral medications

Arms & Interventions

Darolutamide+ADT

Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy

Intervention: Darolutamide (Nubeqa, BAY1841788)

Darolutamide+ADT

Participants will receive darolutamide 600 mg (2 tablets of 300 mg) twice daily with food and ADT of investigator's choice as standard therapy

Intervention: Androgen deprivation therapy (ADT)

Placebo+ADT

Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy

Intervention: Placebo

Placebo+ADT

Participants will receive placebo twice daily with food and ADT of investigator's choice as standard therapy

Intervention: Androgen deprivation therapy (ADT)

Outcomes

Primary Outcomes

Radiological Progression-free Survival (rPFS) Assessed by Central Review

Time Frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months

rPFS used conventional imaging method (99mTc-phosphonate bone scan, CT/MRI scan). rPFS was defined as the time from the date of randomization to the date of progressive disease in malignant soft tissue lesions, progressive disease in malignant bone lesions, or death due to any cause, whichever occurs first. Malignant soft tissue lesions were assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and malignant bone lesions were assessed by Prostate Cancer Clinical Trials Working Group (PCWG3) criteria.

Secondary Outcomes

Overall Survival (OS)(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
Time to Castration-Resistant Prostate Cancer (CRPC)(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
Time to Initiation of Subsequent Anti-cancer Therapy(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
Time to PSA Progression(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
PSA Undetectable Rates (<0.2 ng/mL)(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
Time to Pain Progression(From randomization to the date when 222 rPFS events were observed, approximately 36 months)
Number of Participants With Adverse Events as a Measure of Safety(From start of study drug administration until 30 days after the last administration)