A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Drug: Bicalutamide; Drug: Androgen-deprivation Therapy (ADT); Drug: Prednisolone; Drug: Apalutamide; Drug: Abiraterone; Drug: Enzalutamide; Drug: Docetaxel

Study type: Observational

Funder types: Industry

Identifiers

NCT04034095

CR108675

56021927PCR4009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 979 patients

Sex: Male

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

979 participants in 2 patient groups

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.

Treatment:

Drug: Androgen-deprivation Therapy (ADT)

Drug: Bicalutamide

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.

Treatment:

Drug: Enzalutamide

Drug: Docetaxel

Drug: Abiraterone

Drug: Apalutamide

Drug: Prednisolone

Drug: Androgen-deprivation Therapy (ADT)