Radical prostatectomy without prior biopsy: an initial decision-making algorithm based on PSMA PET/mpMRI

Recent advancements in radiological imaging have raised the possibility of diagnosing prostate cancer (PCa) without biopsy; however, the safety, feasibility, and diagnostic accuracy of this approach require comprehensive evaluation. This study proposes and evaluates an initial decision-making algorithm using PSMA PET/CT and mpMRI for selecting candidates suitable for radical prostatectomy without prior biopsy (RP-WPB).

Patient enrollment was conducted strictly according to the prospectively established decision-making algorithm. Candidates for RP-WPB were required to fulfill four essential criteria: PSA > 4 ng/mL, PI-RADS score≥4, miPSMA score≥2, and co-positive lesions identified on mpMRI and PSMA PET/CT. Patients staged as cT3-4, cN1, or cM1 (solitary metastasis) underwent RP-WPB directly. For patients with stage cT2N0M0, PSA levels were further stratified: those with PSA ranging from 4 to 30 ng/mL were invited to participate in the prospective study, whereas individuals with PSA ≥ 30 ng/mL qualified for RP-WPB only if they satisfied additional conditions, including age≥75 years, PSA density (PSAD) ≥ 0.2 ng/mL/cm³, and willingness to undergo non-neurovascular-bundle-sparing surgery.

From January 2022 to February 2024, 150 patients were prospectively enrolled following the algorithm; 30 patients withdrew, and 120 underwent RP-WPB. Among the latter, 84 patients were classified as cT2N0M0, 27 as cT3-4, 10 as cN1, and 9 as cM1. The detection rate of clinically significant PCa (csPCa) (ISUP grade ≥2) patients was 100% (95% CI: 0.97-1.00, p = 0.176), and pathological concordance was achieved in all cases. No perioperative complications greater than Clavien-Dindo grade Ⅱ occurred.

The proposed algorithm based on PSMA PET/CT and mpMRI for performing RP-WPB demonstrates safety, feasibility, and high diagnostic accuracy, presenting a promising option for selected PCa patients.