Clinical trial · Observational
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
NCT04034095CI-TRIAL-00098929completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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) in the real-world setting in Japan.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Androgen-deprivation Therapy (ADT) | Drug | — | UNRESOLVED |
| Apalutamide | Drug | Apalutamide | ALIAS |
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: ADT alone/ ADT + Bicalutamide
- description
- Participants with diagnosis of metastatic hormone-naive prostate cancer (mHNPC) receiving androgen-deprivation therapy (ADT) alone or ADT plus bicalutamide (combined androgen blockade \[CAB\]) under routine clinical practice will be observed.
- interventionNames
- Drug: Androgen-deprivation Therapy (ADT)
- Drug: Bicalutamide
- label
- Cohort 2: ADT + AAP/Docetaxel/Enzalutamide/Apalutamide
- description
- Participants with diagnosis of mHNPC receiving ADT plus abiraterone plus prednisolone (AAP) or Docetaxel or Enzalutamide or Apalutamide under routine clinical practice will be observed.
- interventionNames
- Drug: Androgen-deprivation Therapy (ADT)
- Drug: Abiraterone
- Drug: Prednisolone
- Drug: Docetaxel
- Drug: Enzalutamide
- Drug: Apalutamide
Primary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
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 malignancies
References
Publications (1)
- DERIVEDMiyake H, Matsumoto R, Fujimoto K, Mizokami A, Uemura H, Kamoto T, Kawakami S, Nakamura K, Maekawa S, Shibayama K, Watanabe A, Ito M, Tajima Y, Matsuyama H, Uemura H. Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer: A 3-year Interim Analysis of the Observational J-ROCK Study. Eur Urol Oncol. 2024 Jun;7(3):625-632. doi: 10.1016/j.euo.2023.12.013. Epub 2024 Jan 30. PMID 38296736