PSMA PET/CT vs. mpMRI in Patients With a High Suspicion of Prostate Cancer: a Head to Head, Parallel, Prospective Trial
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy
- Registration Number
- NCT05297162
- Lead Sponsor
- Istituto Clinico Humanitas
- Brief Summary
This is prospective single-arm case-control study designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy ("experimental test") with mpMRI/TRUS fusion prostate biopsy ("standard test") in men with a high suspicion of PCa after at least one negative biopsy.
- Detailed Description
All patients fulfilling inclusion criteria and providing informed consent to the study will undergo mpMRI and PSMA PET followed by software assisted fusion biopsy, performed in day-hospital setting.
The inclusion criteria are: blood PSA level \>4.0ng/ml; free-to-total PSA ratio \<20%; progressive rise of PSA levels in two consecutive blood samples despite antibiotics; serum blood tests suspicious for PCa; at least one previous negative biopsy (min 12 cores); ASAP and/or high-grade PIN; negative digital rectal examination.
The exclusion criteria are: antiandrogen therapy; prostate needle biopsy \<21 days before PET and/or mpMRI; known active secondary cancer; endorectal coil/probe not applicable; active prostatitis; anaphylaxis against gadolinium-DOTA.
The total duration of the project is 36 months. We expect to enroll the first patient within 1 month after study activation, and complete recruitment within 30 months. Completion of all study analyses on biological materials and experimental imaging is expected within 32 months. The last period is planned for data analysis, biostatistics and manuscript preparation.
All patients eligible according to inclusion criteria and having signed the informed consent will undergo 68Ga-PSMA PET/CT and mpMRI scans within one month distance from each. Dedicated software for image visualization will be used to interpret and quantify 68Ga-PSMA PET/CT SUVmax and SUVratio. Images will be analyzed by an expert nuclear physician; who will proceed to the definition of the suspicious areas candidate to biopsy. mpMRI will be evaluated by an expert radiologist using the following phases: morphological, diffusion-weighted imaging (DWI) and spectroscopy. Reading criteria for mpMRI will be determined based on PI-RADS ver.2 \[29\]. Target delineation on PSMA PET and mpMRI will be performed as previously described \[References\].
Biopsy session will be completed within one month from 68Ga-PSMA PET/CT and mpMRI scans. Targeted TRUS-fusion needle biopsy will be performed for all lesions detected with PET and mpMRI. A subsequent randomized biopsy sampling consisting of 12 samples will be performed from the peripheral region of the prostate. The biopsy frustules will then be evaluated by an expert pathologist on PCa detection.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 128
- Age >18 years
- blood PSA level >4.0ng/ml;
- free-to-total PSA ratio <20%;
- progressive rise of PSA levels in two consecutive blood samples despite antibiotics;
- serum blood tests suspicious for PCa;
- at least one previous negative biopsy (min 12 cores);
- ASAP and/or high-grade PIN;
- negative digital rectal examination.
- antiandrogen therapy;
- prostate needle biopsy <21 days before PET and/or mpMRI;
- known active secondary cancer;
- endorectal coil/probe not applicable;
- active prostatitis;
- anaphylaxis against gadolinium-DOTA.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy Single-arm case-control imaging trial designed to compare in parallel PSMA PET/TRUS (trans-rectal or trans-perineal) fusion biopsy ("experimental test") with mpMRI/TRUS fusion prostate biopsy ("standard test") in men suspected for PCa after at least one negative biopsy.
- Primary Outcome Measures
Name Time Method Sensitivity, Specificity, NPV, PPV, Accuracy 36 months To evaluate the diagnostic performance of PSMA PET-TRUS fusion prostate biopsy in determining the presence of PCa in comparison to mpMRI-TRUS fusion prostate biopsy analyzed in parallel in the same subset of patients.
- Secondary Outcome Measures
Name Time Method Number of spared biopsies 36 months To determine the clinical utility of the "index test" compared to the "standard test in terms of number of spared biopsies compared to mpMRI.
Standardized uptake value and Gleason Score 36 months To determine the correlations between the "index test" standardized uptake values (i.e. SUVmax, SUVratio; SUVmean) and the histopathological characteristics of the specimen (Gleason Score) in order to validate optimal cut-off points able to detect intraprostatic malignancy and differentiate clinically relevant PCa lesions.
Cost-effectiveness 36 months To determine the clinical utility of the "index test" compared to the "standard test in terms of cost-effectiveness.
Trial Locations
- Locations (1)
IRCCS Humanitas Research Hospital
🇮🇹Rozzano, Italy