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Gallium 68 PSMA-11

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Lysine

Patients receive 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11). Participant will be injected IV with 3 to 7 millicurie (mCi) of 68Ga-PSMA-11. Beginning 50 to 100 minutes later, a low-dose computed tomography (CT) scan will be obtained from vertex to mid thighs; followed by a static positron emission tomography (PET) scan over the same .

PET/CT scan using 68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11).

Computed Tomography (CT) scan

68gallium-labeled prostate-specific membrane antigen-11 (68-Ga-PSMA-11), administered by intravenous (IV) injection.

68Ga-PSMA-11

Positron Emission Tomography (PET)

Andrei Iagaru, MD

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

68-Ga PSMA 11 PET/CT for Detection of Recurrent Prostate Cancer After Initial Therapy in Patients With Elevated PSA

Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.

68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.

Positive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.

Scan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows.

* 0.2 to \< 0.5
* 0.5 to \< 1.0
* 1.0 to \< 2.0
* 2.0 to \< 5.0
* ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.

Andrei Iagaru

Professor of Radiology

Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.

* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT

Spots Global Cancer Trial Database for 68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

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