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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002000-41 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-PSMA PET/CT | Experimental | Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-PSMA | Drug | 18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 months |
| Sensitivity for different lesion sites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federica Matteucci, MD | IRST IRCCS, Meldola (FC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irst Irccs | Meldola | FC | 47014 | Italy |
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Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.
| 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. | 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 | Up to 30 months |
| 18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event | Number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0. | Up to 30 months |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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