None listed
Conditions
Interventions
Procedure/Surgery : 1. Experimental group
: This group will use a combined approach of MRI and Prostate Health Index (PHI) to decide whether a biopsy is needed.
1) PI-RADS 1-3: For lesions with lower
the patient will undergo surveillance.
- PHI density = 80: A standard 12-core biopsy will be performed.
2) PI-RADS 4-5: For highly suspicious lesions (PI-RADS 4 to 5), an MRI-targeted biopsy will be p
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Patients aged 20 to under 80 years who have serum PSA = 3 ng/mL or suspected prostate cancer and have been referred for prostate biopsy (within the last 3 months) ? Serum PSA = 20 ng/mL (within the last 3 months) ? Patients deemed suitable to undergo all procedures described in the protocol. ? Patients capable of voluntarily providing informed consent.
Exclusion criteria
Exclusion criteria: ? Patients who have undergone a prior prostate biopsy. ? Patients who have received previous treatment for prostate cancer or undergone prostate cancer surgery. ? Patients who have taken 5-alpha reductase inhibitors within the last 6 months. ? Patients with a history of urinary tract infection or acute prostatitis within the last 3 months. ? Patients with MRI contraindications (e.g., claustrophobia, pacemaker, eGFR = 50 mLs/min). ? Patients with contraindications for prostate biopsy. ? Patients with a history of hip joint replacement or significant orthopedic surgery in the pelvis with metallic implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of clinically significant prostate cancer (=Gleason score 3+4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of clinically insignificant prostate cancer (Gleason score 6);Proportion of men in whom mpMRI score for suspicion of clinically significant cancer was 3, 4 or 5;Proportion of men with omitted prostate biopsy in the experimental group;Proportion of total core number omitted in the experimental group;Proportion of men who go on to definitive local treatment or systemic treatment;Proportion of Gleason grade upgrading in men undergoing radical prostatectomy ;Adverse events of post-biopsy (pain, infection, bleeding, hematospermia);Cumulative detection of clinically significant prostate cancer over the 24-months follow up period, including assessment of delayed cancer diagnosis | — |
Countries
Korea, Republic of
Contacts
Public ContactIn Gab Jeong
Asan Medical Center
Outcome results
None listed