Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
550
18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)
Irst Irccs
Meldola, FC, Italy
Diagnostic role of 18F- PSMA PET /CT (sensitivity)
Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.
Time frame: Up to 30 months
Sensitivity for different PSA values (ranges)
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different ranges of Prostate-Specific Antigen (PSA) values.
Time frame: Up to 30 months
Sensitivity for different lesion sites
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.
Time frame: Up to 30 months
predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.
To evaluate the predictive role of 18F-PSMA PET/CT on disease status, for patients that will start an anticancer treatment. It will be performed the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity The best cut-off value for distinguishing between positive and negative 18F- PSMA PET/CT findings will be determined using Youden's index.
Time frame: Up to 30 months
evaluation of the concordance between 18F-PSMA PET/CT and other methods
To evaluate the concordance between 18F-PSMA PET/CT and PET/CT or the others standard methods, for patients without any treatment, it will be performed by Cohen's kappa coefficient
Time frame: Up to 30 months
18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event
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Number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0.
Time frame: Up to 30 months