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Comparative imaging trial using fast biparametric versus full-sequence multiparametric MRI for detection of Prostate Cancer

Fast biparametric versus full-sequence multiparametric MRI for Detection of Prostate Cancer in Men with Elevated Prostate-Specific Antigen: a prospective, single-center, single-arm, comparative imaging trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006181
Enrollment
365
Registered
2021-05-26
Start date
2021-05-31
Completion date
Unknown
Last updated
2021-06-24

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

Conditions

None listed

Interventions

Others : Before MRI acquisition, patients give consent for undergoing mpMRI and participating this study. Upon image acquisition, an independent research co-ordinator will prepare two image sets which
no category upgrade from category 3 to category 4 for peripheral zone lesions. Two interpretation reports by two independent readers will be provided to a biopsy performer who is blind to allocation r

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Age = 19 and < 80 years B. Patients referred for prostate multiparametric MRI before a prostate biopsy

Exclusion criteria

Exclusion criteria: - History of androgen deprivation therapy or pelvic radiation therapy - Patients with GFR < 50mls/min - Contraindication to MRI (i.e., cardiac pacemaker or claustrophobia) - History of hip prosthesis

Design outcomes

Primary

MeasureTime frame
The proportions of patients who require biopsy (proportions of patients with MRI-positive findings) for identification of suspicious lesions

Secondary

MeasureTime frame
To compare clinically significant prostate cancer (csPCa; defined as Gleason = 7 (3+4) cancer) detection rates detected by mpMRI and fast-bp MRI;To compare clinically insignificant prostate cancer (defined as Gleason = 6) detection rates detected by mpMRI and fast-bp MRI;To compare the number of suspicious lesions on a per-lesion level;The number of positive biopsy cores per total biopsy cores of mpMRI and fast-bpMRI;Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of mpMRI and fast-bpMRI for detection of csPCa on a patient-basis and lesion-basis;Proportion of indeterminate category (PI-RADS category 3)

Countries

Korea, Republic of

Contacts

Public ContactKye Jin Park

Asan Medical Center

kyejin629@gmail.com+82-2-3010-0132

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026