Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients With Prostate Cancer.

Study Overview
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Brief Summary
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Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.

Detailed Description
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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.

Official Title
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Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients With Prostate Cancer.

Conditions
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18F-PSMA, Prostate Cancer

Intervention / Treatment
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* Drug: 18F-PSMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have histologically or cytologically confirmed prostate cancer Male, aged >18 years on the day of signing and dating the informed consent form. Previous radical treatment for prostate cancer (radiotherapy or surgery) Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: Hormonotherapy in the last 6 months No radiotherapy in the last 6 months. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent. Medical or psychological conditions that would not permit the subject to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-PSMA PET/CT<br>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. | Drug: 18F-PSMA<br>* 18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-PSMA, PET/CT, Prostate Cancer, Diagnostic, Biochemical relapse, Negative standard imaging, Radically treated