Comparing Bp-MRI and Mp-MRI for Prostate Cancer Screening Accuracy
A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy
Chang Gung Memorial Hospital
370 participants
May 1, 2024
INTERVENTIONAL
Conditions
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 Criteria6
- Men ≥50 years of age
- Clinical suspicion of prostate cancer and indicated for prostate biopsy
- Serum Prostate-specific antigen (PSA) between 4\~20 ng/mL
- Eligible for MRI study
- Digital rectal examination ≤ cT2 (organ-confined cancer)
- Able to provide written informed consent.
Exclusion Criteria10
- Prior prostate biopsy in the 6 months before screening visit
- Prior diagnosis of prostate cancer
- 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)
- Contraindicated to MRI study: contrast medium allergy, claustrophobia, or other contraindications (e.g.: intra-abdominal metal foreign bodies).
- Patients without histological results of prostate biopsies due to patient refusal for biopsy or loss of follow up before biopsy being done
- Patients have prior treatments for prostate cancers or any kinds of hormone therapy, immunotherapy, chemotherapy, radiation therapy of the pelvic cavity.
- Patients' withdrawal of informed consents of this study
- Withdrawal criteria:
- Patients could not complete the scheduled MRI examinations
- MRI images of insufficient quality to localized csPCA or to exclude the presence of csPCA
Interventions
Biparametric MRI is considered less comprehensive compared to multiparametric MRI (mp-MRI), which includes additional parameters like dynamic contrast-enhanced MRI (DCE-MRI). However, bp-MRI offers a simpler, faster, and often less expensive alternative that still provides critical diagnostic information, particularly in the detection of clinically significant prostate cancer. It's commonly used where less comprehensive assessment is sufficient or in situations where contrast use is contraindicated.
Multiparametric MRI is highly valued for its ability to improve the detection and characterization of clinically significant prostate cancer, aid in biopsy guidance, and help in treatment planning and monitoring. Its comprehensive approach provides crucial insights that are not as readily available through simpler imaging modalities like biparametric MRI (bp-MRI).
Locations(1)
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NCT06402552