Comparing two types of 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

This study is testing which type of MRI, bi-parametric or multi-parametric, works better at finding significant prostate cancer in men over 50 with high PSA levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 370 (estimated)
• Ages: 50 Years to 90 Years
• Sex: Male
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Taoyuan City)
• Trial ID: NCT06402552 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare bi-parametric MRI (bp-MRI) and multi-parametric MRI (mp-MRI) for their effectiveness in detecting clinically significant prostate cancer in men aged 50 and older with elevated PSA levels. Participants will undergo MRI scans followed by targeted and systematic biopsies based on the MRI findings. The study will evaluate the proportion of men diagnosed with clinically significant prostate cancer and other related outcomes. The trial is conducted at Chang Gung Memorial Hospital in Taiwan.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 50 and older who have a clinical suspicion of prostate cancer and a PSA level between 4-20 ng/mL.

Not a fit: Patients who have a prior diagnosis of prostate cancer or those who are contraindicated for biopsy or MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer screening, leading to better diagnosis and treatment outcomes for patients.

How similar studies have performed: Other studies have shown promising results in using MRI for prostate cancer detection, making this approach both relevant and potentially impactful.

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

Where this trial is running

Taoyuan City

• Chang Gung Memorial Hospital, Linkou — Taoyuan City, Taiwan (Recruiting)

Study contacts

• Study coordinator: See-Tong Pang, MD. PhD.

Conditions Randomized Controlled Trial; Prostate Cancer; Magnetic Resonance Imaging