Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy

Summary

3.1 Study Objectives: 3.1.1 Primary objective: The investigators aim to address these questions for Taiwan males suspicious of csPCA, with PSA range of 4-20 ng/ml by conducting a RCT trial. 3.2 Study endpoints: 3.2.1 Primary endpoint: The proportion of men with clinically significant Prostate cancer(csPCa), defined as a diagnosis of ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer, in at least one biopsy core. 3.2.2 Secondary endpoints: 1. The proportion of men with a diagnosis of any PCa 2. The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa) 3. The proportion of men with a diagnosis of csPCa 4. Only in targeted biopsy 5. Only in systematic biopsy 6. The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.

Eligibility

Inclusion Criteria:

1. Men ≥50 years of age
2. Clinical suspicion of prostate cancer and indicated for prostate biopsy
3. Serum Prostate-specific antigen (PSA) between 4\~20 ng/mL
4. Eligible for MRI study
5. Digital rectal examination ≤ cT2 (organ-confined cancer)
6. Able to provide written informed consent.

Exclusion Criteria:

1. Prior prostate biopsy in the 6 months before screening visit
2. Prior diagnosis of prostate cancer
3. Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
4. Contraindicated to MRI study: contrast medium allergy, claustrophobia, or other contraindications (e.g.: intra-abdominal metal foreign bodies).
5. Patients without histological results of prostate biopsies due to patient refusal for biopsy or loss of follow up before biopsy being done
6. Patients have prior treatments for prostate cancers or any kinds of hormone therapy, immunotherapy, chemotherapy, radiation therapy of the pelvic cavity.
7. Patients' withdrawal of informed consents of this study

Withdrawal criteria:

1. Patients could not complete the scheduled MRI examinations
2. MRI images of insufficient quality to localized csPCA or to exclude the presence of csPCA

Conditions4

Browse More Trials