The Value of Dual-parametric Magnetic Resonance Combined With Regional Saturation Biopsy in Patients With Suspected Prostate Cancer

Arms (2)

1. type

   EXPERIMENTAL

   label

   MRI negative without biopsy

   description

   If a lesion with a PI-RADS score of 3 or higher was identified during the initial examination, a regional saturation biopsy of the prostate was conducted, as clinical suspicion of prostate cancer had been raised. Should the initial prostate biopsy yield negative results, the patient would be placed in the follow-up cohort. Targeted biopsy in conjunction with a 12-needle systematic biopsy would only be performed in cases where there was high suspicion of MRI persistence (a PI-RADS v2.1 score of 4 or 5) or if the lesion showed signs of progression. If no lesions with a PI-RADS v2.1 score of 3 or higher were detected during the initial examination, the patients would be entered into the follow-up cohort. Reginal saturation biopsy would be performed when MRI showed progression. If the initial prostate biopsy was negative, the patient would again be entered into the follow-up cohort.

   interventionNames

   1. Procedure: Follow up if MRI is negative

2. type

   ACTIVE_COMPARATOR

   label

   MRI negative with systemic biopsy

   description

   Focal saturation biopsy of the prostate was performed if a PI-RADS v2.1 score ≥3 lesion was detected during the initial examination. If no PIRADS v2.1 score ≥3 lesions were identified, a 12-needle systematic biopsy was performed. If the initial prostate biopsy was negative for prostate cancer, it was entered into the follow-up cohort. When the following clinical indications for repeat biopsy were met ① initial biopsy pathology showed no evidence of malignancy, but atypical small follicular hyperplasia was found, or high-grade epithelial neoplasia in more than 3 needles, with atypical glands visible in the surrounding area present; ② review of persistent elevation of serum PSA or abnormalities in the imaging follow up; and ③ review of serum PSA 4\~10 ng/ml in conjunction with f/t PSA, PSAD, PSAV, and PHI, abnormal rectal digital examination or other imaging findings, then target biopsy combined with 12-needle systemic biopsy was performed.