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

NCT06402552 | Recruiting

• 1 other identifier: 202400317A3
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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. 1.The proportion of men with a diagnosis of any PCa
2. 2.The proportion of men with a diagnosis of clinically insignificant PCa, defined as ISUP grade group 1 PCa (ISUP 1 PCa)
3. 3.The proportion of men with a diagnosis of csPCa
4. 4.Only in targeted biopsy
5. 5.Only in systematic biopsy
6. 6.The proportion of csPCa of all suspicious lesions from bp-MRI and mp-MRI.

Conditions

Randomized Controlled Trial; Prostate Cancer; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Prevalence of Clinically Significant Prostate Cancer among Men as Defined by ISUP Grade Group ≥2 in Biopsy Samples

  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.

  2-3 weeks

Secondary Outcomes (1)

• Prostate Cancer Diagnosis Rates and Specifics in Biopsy Methods

  4-6 weeks

Study Arms (1)

prostate cancer

EXPERIMENTAL

Patients who are suspicious of prostate cancers with abnormal digital examination, or abnormal ultrasound and having a pre-MRI and were scheduled to receive prostate biopsy will be enrolled in this study. Patients will be randomized in a 1:1 manner to bp-MRI and mp-MRI. Patients with clinical suspicion of prostate cancer on MRI with PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1)

Diagnostic Test: bp-MRI prostate; Diagnostic Test: mp-MRI prostate

Interventions

bp-MRI prostate DIAGNOSTIC_TEST

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.

prostate cancer

mp-MRI prostate DIAGNOSTIC_TEST

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).

prostate cancer

Eligibility Criteria

• Age: 50 Years - 90 Years
• Gender Eligibility Details: Male patient only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

See-Tong Pang, MD. PhD.

CONTACT

0975365572; jacobpang@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

TW (1)