Prostate Cancer
Conditions
Keywords
Bone Metastasis, PET/CT
Brief summary
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.
Interventions
DRUG[68Ga]PSMA
Patients will receive up to 6 mCi of \[Ga-68\]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
DRUGFlourine-18 [F-18] Sodium Fluoride (NaF)
Patients will receive 8-12 mCi of \[F-18\]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
DIAGNOSTIC_TESTPET/CT
Patients will receive \[68Ga\]PSMA with a PET/CT and Flourine-18 \[F-18\] Sodium Fluoride (NaF) with a PET/CT
Sponsors
University Hospitals Cleveland Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis | Up to 90 minutes | Classified using a 5-point score with one being definitely metastatic and five being definitely benign |
Secondary
| Measure | Time frame |
|---|---|
| Focally increased [Ga-68]PSMA uptake as measured by PET/CT | Up to 90 minutes |
Countries
United States
Outcome results
None listed