A Randomized Controlled Trial Comparing Bp-MRI and Mp-MRI on the Screening Accuracy for Clinically Significant Prostate Cancer Before MRI-fusion Targeted Biopsy

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital, Linkou
RECRUITING
Taoyuan
Contact Information
Primary
See-Tong Pang, MD. PhD.
jacobpang@cgmh.org.tw
0975365572
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 370
Treatments
Experimental: prostate cancer
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)
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov