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

Launched by CHANG GUNG MEMORIAL HOSPITAL · May 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two types of magnetic resonance imaging (MRI) to see which one is better at detecting significant prostate cancer in men. The study is specifically for men aged 50 and older who have signs that may indicate prostate cancer, based on their prostate-specific antigen (PSA) levels being between 4 and 20 ng/mL. The goal is to find out how many participants have clinically significant prostate cancer, which is defined as a more serious form of the disease that needs treatment.

To take part in this trial, men must be at least 50 years old, have a suspicion of prostate cancer that requires a biopsy, and be able to undergo an MRI without any issues. However, those who have had a biopsy in the last six months, already have a diagnosis of prostate cancer, or have certain medical conditions that prevent them from having a biopsy or MRI cannot participate. If eligible, participants can expect to undergo imaging tests and possibly a biopsy to help determine if they have significant prostate cancer. This trial is currently recruiting participants, and it aims to provide important insights into how to better screen for prostate cancer.

Gender

MALE

Eligibility criteria

• 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