The Registry to Observe Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer in Japan

The Registry to Observe Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer in Japan - Japan mHNPC Registry

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000037127

Enrollment

1000

Registered

2019-06-21

Start date

2019-07-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk metastatic hormone-naive prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male aged more than 20 years. 2. Documented diagnosis of mHNPC after 1 May 2019. 3. Should have at least 2 of the 3 following high-risk factors: a Gleason score of more than 8, at least 3-bone lesions, or the presence of visceral metastasis when diagnosed with mHN PC. 4. Willing to receive ADT containing regimens for high-risk mHNPC in the hospital which have the contract with sponsor for this study, or patient received a regimen containing ADT for high-risk mHNPC. 5. Possess Japanese nationality. 6. Each patient (or their legally acceptable representative) must sign an 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 IEC/IRB.

Exclusion criteria

Exclusion criteria: 1. Have any other active malignancies.

Design outcomes

Primary

Measure	Time frame
To longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for patients with high-risk mHNPC in the real-world setting in Japan	—

Secondary

Measure	Time frame
1) Proportion of patients who achieve prostate-specific antigen (PSA) less than 0.2 ng/mL within a year from registration 2) PSA progression-free survival (PSA-PFS) and 2-year PSA-PFS rate 3) PFS and 3-year PFS rate 4) OS and 3-year OS rate 5) Cancer specific survival (CSS) and 3-year CSS rate 6) Serum testosterone kinetics (if appropriate) 7) Subsequent treatment 8) Time to subsequent treatment (TTST) for prostate cancer 9) Time to symptomatic skeletal event (TTSSE) 10) Bone mineral density (BMD) kinetics (if appropriate) 11) Safety in the usual clinical practice 12) PRO by FACT-P, PHQ-9, and MoCA (if appropriate)	—

Measure

Time frame

1) Proportion of patients who achieve prostate-specific antigen (PSA) less than 0.2 ng/mL within a year from registration 2) PSA progression-free survival (PSA-PFS) and 2-year PSA-PFS rate 3) PFS and 3-year PFS rate 4) OS and 3-year OS rate 5) Cancer specific survival (CSS) and 3-year CSS rate 6) Serum testosterone kinetics (if appropriate) 7) Subsequent treatment 8) Time to subsequent treatment (TTST) for prostate cancer 9) Time to symptomatic skeletal event (TTSSE) 10) Bone mineral density (BMD) kinetics (if appropriate) 11) Safety in the usual clinical practice 12) PRO by FACT-P, PHQ-9, and MoCA (if appropriate)

—

Countries

Japan

Contacts

Public ContactYohei Tajima

Janssen Pharmaceutical K.K. Medical Affairs Operations Dept.

ytajima4@its.jnj.com03-4411-7700

Outcome results