Apalutamide
DrugApalutamide 240 mg (4*60 mg tablets) will be administrated orally once daily.
Other names: JNJ-56021927, ARN-509
NCT Number: NCT04108208
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).
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Phase 4
Beijing Friendship Hospital, Beijing, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Apalutamide 240 mg (4*60 mg tablets) will be administrated orally once daily.
Other names: JNJ-56021927, ARN-509
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 frame: From randomization until first documented PSA progression (up to 3 years 3 months)
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: Up to 6 years 4 months
Time frame: Up to 6 years 4 months
Time frame: Up to 6 years 4 months
Time frame: Presdose: Day 1 of Cycles 1, 2, 3, and 6; 2 hours postdose: Day 1 of Cycles 1 and 3
Janssen Research & Development, LLC
Industry
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03834493
Genital Diseases, Genital Diseases, Male
Mobile, Alabama, United States
View Trial DetailsNCT02854982
Genital Diseases, Genital Diseases, Male
Nîmes, Gard, France
View Trial DetailsNCT03421015
Disease Attributes, Genital Diseases
Lille, France
View Trial DetailsNCT06104449
Genital Diseases, Genital Diseases, Male
Kashiwa, Chiba, Japan
View Trial Details