The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily.
Matching placebo will be administered orally.
Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.
Time to Prostate Specific Antigen (PSA) Progression (TTPP) Based on Prostate Cancer Working Group 2 (PCWG2) Criteria
Time to prostate specific antigen progression (TTPP) was defined as the time from randomization to the first date of documented PSA progression based on PCWG2 criteria. PCWG2 was defined as the PSA progression as 1) the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) or more from the Nadir was documented, which was confirmed by a second value obtained 3 or more weeks later. 2) Where no decline from baseline was documented as a 25% increase from the baseline value along with an increase in absolute value of 2 ng/mL or more after 12 week of treatment. Kaplan-Meier method was used for the analysis.
Time frame: From randomization until first documented PSA progression (up to 3 years 3 months)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Up to 6 years 4 months
Number of Participants With Grade 3 or Higher Abnormalities in Laboratory Values
Time frame: Up to 6 years 4 months
Percentage of Participants Who Achieved Prostate Specific Antigen (PSA) Response (>=50% PSA Reduction)
Time frame: Up to 6 years 4 months
Plasma Concentration of Apalutamide and Its Metabolite (N-desmethyl Apalutamide)
Time frame: Presdose: Day 1 of Cycles 1, 2, 3, and 6; 2 hours postdose: Day 1 of Cycles 1 and 3
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Beijing Friendship Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Beijing Hospital
Beijing, China
Hunan Cancer hospital
Changsha, China
Sichuan Provincial Peoples Hospital
Chengdu, China
Chongqing University Cancer Hospital
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
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