The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are: * Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer. * Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer. The data of participants was collected prospectively.
The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination, serum prostate-specific antigen detection, transrectal prostate ultrasound, and multi-parameter magnetic resonance imaging. However, these methods lack sufficient specificity for the diagnosis of prostate cancer. Therefore, prostate biopsy is still the gold standard for the diagnosis of prostate cancer. mpMRI has good accuracy in detecting clinically significant prostate cancer, but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm, and false positive results may occur for benign diseases such as prostatitis. The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 1.5T or 3.0T. The application of 3.0T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer, making it the most commonly used magnetic field strength for mpMRI. The main problems of 3.0T prostate magnetic resonance examinations are low specificity (false positive results) and insufficient accuracy in determining tumor staging. At present, there is no research and exploration on the use of 5.0T magnetic resonance in the diagnosis of prostate cancer in the world. This study intends to analyze and compare the differences between 5.0TbpMRI and 3.0TbpMRI in the diagnosis of prostate cancer through a prospective, paired-design diagnostic trial, and try to explore whether 5.0TbpMRI can improve the limitations of 3.0TbpMRI in the diagnosis of prostate cancer.
Study Type
OBSERVATIONAL
Enrollment
150
All patients were required to underwent transperineal prostate biopsy (Systemetic + Targeted) and have corresponding pathological diagnosis results.
Department of Urology, The First Affiliated Hospital of USTC
Hefei, Anhui, China
RECRUITINGCompare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.
Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1. Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.
Time frame: through study completion, an average of 1 month
Evaluation of the reliability (repeatability) of the diagnostic test.
The inter-reader agreement was evaluated using Cohen's kappa analysis (Cohen's kappa coefficeint, P-value and 95%CI)
Time frame: through study completion, an average of 1 month
Comparative analysis of the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the stage of prostate cancer
Accuracy of prostate capsule invasion, seminal vesicle invasion and pelvic lymph node metastasis.
Time frame: through study completion, an average of 2 months
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