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Urine Test for Prostate Cancer Risk Assessment: A Multi-Center Study

Evaluation of the Efficacy of the Risk Score (Pure Index) Using Urinary Spermine Measurements for Secondary Screening of Prostate Cancer: A Multicenter Study - Prostate Cancer Screening Study of Risk Score (Pure Index) Using Urinary Spermine

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000055166
Enrollment
200
Registered
2024-08-05
Start date
2024-08-04
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

Suspected Prostate Cancer

Interventions

None listed

Sponsors

Juntendo University, Graduate School of Medicine
Lead Sponsor
Juntendo University Nerima Hospital, Graduate School of Medicine Nippon Medical School, Graduate School of Medicine
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male patients aged 18 years or older at the time of obtaining consent. Male patients suspected of having prostate cancer, with PSA test results meeting the following criteria (based on prostate cancer guidelines): Aged 50 to 65 years: PSA level of 3.0 ng/mL or higher Aged 65 to 70 years: PSA level of 3.5 ng/mL or higher Other age groups: PSA level of 4.0 ng/mL or higher Patients scheduled for a prostate biopsy due to suspicion of prostate cancer. Individuals who have been adequately informed about the study, have a sufficient understanding, and have provided written consent of their own free will to participate in this study.

Exclusion criteria

Exclusion criteria: Patients under 20 years of age at the time of obtaining consent. Dialysis patients. Patients who have had a urinary tract infection requiring antibiotic treatment within 6 weeks prior to urine collection. Patients who have had a Foley catheter or cystoscope inserted within 6 weeks prior to urine collection. Patients who have undergone a digital rectal examination within 7 days prior to urine collection. Patients who have used 5-alpha reductase inhibitors within 6 months prior to urine collection. Patients who refuse to consent or are unable to consent to this study. Others deemed unsuitable as study subjects by the principal investigator.

Design outcomes

Primary

MeasureTime frame
ROC Curve AUC for the PURE Index

Countries

Japan

Contacts

Public ContactYoshihiro Ikehata

Juntendo University, Graduate School of Medicine Department of Urology

y-ikehata@juntendo.ac.jp03-5802-1227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026