DEPROMP Trial: the additive value of PSMA-PET/CT-guided biopsy for prostate cancer management in biopsy naïve men—study protocol for a randomized trial

Table 1 Study objectives

Primary objective
➢ To determine the proportion of patients in whom management plans are changed by additional PET-TB compared to the SOC using SB and MR-TB
Secondary study objectives
➢ To determine the additive value of PET/MR-TB for detecting csPCA in men undergoing initial biopsy for suspected PCA compared to SOC
➢ To determine sensitivity, specificity, PPV, NPV, and diagnostic accuracy for PCA and csPCA of MRI, PSMA-PET/CT, biopsy modalities (SB vs. MR-TB vs. PET-TB vs. PET/MR-TB), and the respective imaging classifications (PIRADS V2.1 classification, PROMISE miTNM classification V1.0, miPSMA score)
➢To determine the additive value of more than one targeted biopsy per MRI- or PSMA-PET/CT suspicious lesion
➢ To determine the concordance of tumor burden defined preoperatively by MRI and PSMA-PET/CT and tumor extent in the prostatectomy specimen using whole-mount sections
➢ To determine the frequencies of predefined adverse events CTCAE grade 3 in the context of PET/MR-TB in relation to the total number of biopsy cores taken and anticoagulants intake
➢ To determine the concordance of biomarker expression (PTEN and PSMA) between tumor-bearing prostate specimens (biopsy cores vs. prostatectomy specimens) as well as concordance between PSMA expression of PSMA-PET/CT imaging and prostatectomy specimens and tumorous lymph nodes

PET Positron-emission tomography, PET-TB ultrasound-guided PSMA-PET/CT fusion biopsy, SOC Standard of care, SB Systematic 12-core ultrasound biopsy of the prostate, MR-TB ultrasound-guided MRI fusion biopsy, PET/MR-TB combined SB + MR-TB + PET-TB, PCA Prostate cancer, csPCA clinically significant prostate cancer, defined as PCA with Gleason score ≥ 7a, PPV Positive predictive value, NPV Negative predictive value, MRI Multiparametric magnetic resonance imaging, PI-RADS Prostate Imaging-Reporting and Data System, PSMA Prostate-specific membrane antigen, PROMISE Prostate Cancer Molecular Imaging Standardized Evaluation, miTNM molecular imaging TNM system, miPSMA score molecular imaging PSMA expression score, CTCAE Common Terminology Criteria for Adverse Events

ISSN: 1745-6215