Status:
COMPLETED
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
20+ years
Brief Summary
The purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) i...
Eligibility Criteria
Inclusion
- 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
- \- has any other active malignancies
Key Trial Info
Start Date :
July 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 13 2024
Estimated Enrollment :
979 Patients enrolled
Trial Details
Trial ID
NCT04034095
Start Date
July 8 2019
End Date
August 13 2024
Last Update
December 15 2025
Active Locations (77)
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1
Akita University Hospital
Akita, Japan, 010-8543
2
Juntendo University Hospital
Bunkyō City, Japan, 113 8431
3
Tokyo Medical and Dental University Hospital
Bunkyō City, Japan, 113 8519
4
Chiba University Hospital
Chiba, Japan, 260 8677