A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
The Registry to Observe Clinical Outcomes of Patients With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Sponsor: Janssen Pharmaceutical K.K.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants who Achieve Prostate-specific Antigen (PSA) <=0.2 ng/mL Within a Year from Registration
Time frame: 1 year
PSA Progression-free Survival (PSA-PFS)
Time frame: Up to 5 years
Percentage of Participants with PSA-PFS
Time frame: 2 years
Progression-free Survival (PFS)
Time frame: Up to 5 years
Eligibility Criteria
Inclusion Criteria: * Documented diagnosis of metastatic, hormone-naïve prostate cancer (mHNPC) after 1 May 2019 * Should have at least 2 of the 3 following high-risk factors: a Gleason score of greater than or equal to (\>=) 8, at least 3-bone lesions, or the presence of visceral metastasis * Willing to receive androgen-deprivation therapy (ADT) containing regimens for high-risk metastatic, hormone-naïve prostate cancer (mHNPC) in the hospital which have the contract with sponsor for this study, or patient received a regimen containing ADT for high-risk mHNPC * Possess Japanese nationality * Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study. For dead cases, the ICF can be waived after approved by Independent Ethics Committee/Institutional Review Board (IEC/IRB) Exclusion Criteria: \- has any other active mal…
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