Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen ([Ga-68]PSMA) for detection of bone metastasis in patients with prostate cancer. For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information about the extent of bone metastases. Therefore, the investigators will compare[Ga-68]PSMA PET/CT with Flourine-18 [F-18] Sodium Fluoride (NaF), which is a high resolution bone scan. [F-18]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.[Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.

Official Title
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Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: [68Ga]PSMA
* Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)
* Diagnostic Test: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Patients must have a history of prostate cancer 2) Patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging. 3) Patients ≥ 18 years old 4) Patients able to tolerate PET/CT scans 5) Informed written consent must be given and signed Exclusion Criteria: 1. Subjects who do not meet the noted inclusion criteria 2. Patients < 18 years old 3. Subjects who refuse to give or are unable to sign the informed consent 4. Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks 5. Patients with a known allergy against Ga-68 PSMA or F-18 NaF

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| [F-18]NaF<br>Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging. | Drug: [68Ga]PSMA<br>* Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging<br>Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)<br>* Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.<br>Diagnostic Test: PET/CT<br>* Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT<br>|
| [Ga-68]PSMA<br>Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging | Drug: [68Ga]PSMA<br>* Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging<br>Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)<br>* Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.<br>Diagnostic Test: PET/CT<br>* Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis | Classified using a 5-point score with one being definitely metastatic and five being definitely benign | Up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Focally increased [Ga-68]PSMA uptake as measured by PET/CT |  | Up to 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Metastasis, PET/CT