BIOPSTAGE is a prospective, non-randomized, diagnostic, multi-cohort investigational study to evaluate the impact of pelvic Multi-parametric 3-Tesla magnetic resonance imaging (mp-3TMRI) and whole-body 68Ga-PSMA PET/CT for diagnosis of clinically-significant prostate cancer and pre-surgical staging.
The aim of this study is to characterize the diagnostic accuracy of both multi-parametric pelvic Magnetic Resonance Imaging (MRI) (T2-weighted, Diffusion Weighted Imaging (DWI), Dynamic Contrast Enhancement (DCE) and 68Ga-chelated Prostate Specific Membrane Antigen ligand (68Ga-PSMA) Positron Emission Tomography/Computed Tomography (PET /CT) in three cohorts of patients: * COHORT 1 Guiding prostate biopsies in men with clinical suspicion and/or unconfirmed clinically-significant prostate cancer (CS-PCa) on initial prostate biopsy; * COHORT 2 Targeting repeat prostate biopsy in patients on Active Surveillance (PRIAS Study), scheduled for PRIAS repeat biopsy; * COHORT 3 Providing pelvic / whole-body pre-surgical staging in: * 3a: men with high-risk PCa (HR-PCa); * 3b: men candidates for nerve sparing surgery (NSS);
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
261
multi-parametric pelvic MRI
68Ga-PSMA PET/CT
AUSL della Romagna
Forlì, FC, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
sensitivity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging will be calculated as the ratio between the number of positive cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams
Time frame: up to 36 months
specificity of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
specificity will be calculated considering negative cases at 68Ga-PSMA PET/CT or mp-3TMRI and number of patients who underwent to these exams
Time frame: up to 36 months
Positive predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
Positive predictive value will be calculated considering the ratio between positive patient at 68Ga-PSMA PET/CT/mp-3TMRI confirmed as positive throughout biopsy and overall positive patient at 68Ga-PSMA PET/CT/mp-3TMRI
Time frame: up to 36 months
negative predictive value of both 68Ga-PSMA PET/CT and mp-3TMRI imaging
negative predictive value will be calculated considering the ratio between negative patient at 68Ga-PSMA PET/CT/mp-3TMRI confirmed as negative throughout biopsy and overall negative patient at 68Ga-PSMA PET/CT/mp-3TMRI
Time frame: up to 36 months
Incidence of adverse events
The number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated for each cohort and diagnostic procedure, using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 should be used to assess and grade AE severity.
Time frame: up to 30 days following study procedures
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.