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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
669
Coated tablet, oral administration
Coated tablet matching Darolutamide in appearance, oral administration
Luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or orchiectomy
Radiological Progression-free Survival (rPFS) Assessed by Central Review
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.
Time frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months
Overall Survival (OS)
Time from the date of randomization to the date of death from any cause.
Time frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to Castration-Resistant Prostate Cancer (CRPC)
Time from the date of randomization to the date of first castration resistant event (radiological progression, Prostate-specific antigen (PSA) progression or symptomatic skeletal events, whichever occurs first).
Time frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to Initiation of Subsequent Anti-cancer Therapy
Time from the date of randomization to initiation of first subsequent anti-cancer therapy for prostate cancer.
Time frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to PSA Progression
Time from the date of randomization to the date of first prostate-specific antigen (PSA) progression. PSA progression with serum testosterone being at castrate level \<0.50 ng/mL, is defined as a ≥25% increase above the nadir (lowest at or after baseline) value and an increase in absolute value of ≥2 ng/mL above nadir, and is at least 12 weeks from randomization date, which is confirmed by a second value 3 or more weeks later. All PSA values between the initial assessment meeting the PSA progression criteria and confirmation assessment must be ≥2 ng/mL and ≥25% increase above nadir, serum testosterone at castrate levels \<0.50 ng/mL is requested at initial assessment.
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Nepean Hospital
Kingswood, New South Wales, Australia
Northern Cancer Institute
St Leonards, New South Wales, Australia
Macquarie University Hospital - Oncology Department
Sydney, New South Wales, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Peninsula Oncology Centre
Frankston, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Assistência Multidisciplinar em Oncologia (AMO)
Salvador, Estado de Bahia, Brazil
Hosp. Araujo Jorge da Associação de Combate ao Câncer
Goiânia, Goiás, Brazil
Hospital da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Cetus Oncologia Hospital Dia
Belo Horizonte, Minas Gerais, Brazil
...and 121 more locations
Time frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months
PSA Undetectable Rates (<0.2 ng/mL)
Percentage of subjects with detectable PSA values of ≥0.2 ng/mL at baseline which became undetectable with any PSA values \<0.2 ng/mL during the period between randomization and 30 days after last dose of study drug or start of new anti-cancer therapy whichever occurred earliest, based on the subjects had detectable PSA value at baseline.
Time frame: From randomization to the date when 222 rPFS events were observed, approximately 36 months
Time to Pain Progression
Pain progression was assessed by Question 3 (Q3) of the BPI-SF questionnaire related to the worst pain in the last 24 hours (worst pain subscale \[WPS\]) taken as an average for post baseline score, or initiation of short or long-acting opioids for malignant disease for ≥7 consecutive days after randomization. Pain progression was defined as: (1) for asymptomatic subjects with WPS=0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization; (2) for symptomatic subjects with WPS \>0 at baseline, an increase of 2 or more points in the WPS score from nadir observed at 2 consecutive evaluations ≥4 weeks apart and a WPS ≥5, or initiation of short- or long-acting opioid use for malignant disease for ≥7 consecutive days after randomization.
Time frame: 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
An AE is any untoward medical occurrence in a patient or clinical study participant, after providing written IC for participation in the study, may or may not be temporally associated with the use of study drug, whether or not considered related to the study drug. Treatment-emergent AE (TEAE) is defined as any event arising or worsening after the first dose of study drug until 30 days after the last dose of study drug.
Time frame: From start of study drug administration until 30 days after the last administration