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MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study

MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005999
Enrollment
300
Registered
2021-03-16
Start date
2020-03-27
Completion date
Unknown
Last updated
2021-03-22

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

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: •1. Men undergoing a first-time prostate biopsy to rule out cancer •2. Serum PSA =3ng/mL, =20ng/mL •3. Age=50 years, =80 years •4. Clinical stage =T2c •5. Patients must be able to provide written informed consent.

Exclusion criteria

Exclusion criteria: •1. Patients has any prior needle biopsy of the prostate •2. Patients has a prior history of prostate cancer •3. Patients has a prior history of pelvic radiation therapy or androgen deprivation therapy •4. Patients has a prior history of BPH operation •5. Patient with uncorrectable coagulopathies •6. Unable to tolerate a TRUS guided biopsy. •7. Patients had 5-alpha reductase inhibitor in the past six months. •8. The patient has had a urinary tract infection or acute prostatitis in the last three months. •9. Any contraindication to MRI (severe claustrophobia, pacemaker, MRI-incompatible prosthesis, eGFR =50mls/min)

Design outcomes

Primary

MeasureTime frame
1.Proportion of clinically significant prostate cancer (=Gleason score 3+4) [ Time Frame: 2 week after the procedure ]

Secondary

MeasureTime frame
1.Proportion of clinically insignificant prostate cancer (Gleason score 6) [ Time Frame: 2 week after the procedure ]

Countries

Korea, Republic of

Contacts

Public ContactBumjin Lim

Asan Medical Center

Outcome results

None listed

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