Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI

Clinical research on [-2] proPSA measurement in a diagnosis of prostate cancer: prostate health index trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI - Importance of [-2] proPSA measurement in a diagnosis of PROstate cancer: Prostate HEalth index Trial. Side study: head to head comparison between [-2] proPSA-related indices and MRI (PROPHET-MRI).

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047187

Enrollment

109

Registered

2022-03-16

Start date

2022-03-01

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

prostate cancer

Interventions

None listed

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Patients enrolled in PROPHET 2) Patients who underwent MRI before prostate biopsy

Exclusion criteria

Exclusion criteria: 1) Patients who are intent to withdraw from the study until the date of predefined deadline

Design outcomes

Primary

Measure	Time frame
Comparison of diagnostic accuracy (area under ROC curve, sensitivity, specificity, positive predictive value, negative predictive value) between [-2] proPSA-related indices and MRI.	—

Secondary

Measure	Time frame
1) Risk for missing clinical significant prostate cancer in MRI-negative cases, and supplemental performance of [-2] proPSA-related indices. 2) Risk for missing clinical significant prostate cancer in cases under cutoff values of [-2] proPSA-related indices, and supplemental performance of MRI.	—

Countries

Japan

Contacts

Public ContactKazuro Ito

Kurosawa Hospital Department of Urology

kzito@gunma-u.ac.jp027-352-1166

Outcome results