MR-target Biopsy vs. TRUS-biopsy in Men with Suspicious Prostate Cancer: A paired Cohort blinded Study
- Conditions
- Neoplasms
- Registration Number
- KCT0005999
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 300
•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.
•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)
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Proportion of clinically significant prostate cancer (=Gleason score 3+4) [ Time Frame: 2 week after the procedure ]
- Secondary Outcome Measures
Name Time Method 1.Proportion of clinically insignificant prostate cancer (Gleason score 6) [ Time Frame: 2 week after the procedure ]