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

University Hospitals (UH)

Status: Completed

Conditions: Prostate Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT05527483

STUDY20220121

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

32 participants in 2 patient groups

[F-18]NaF

Description:

Patients will receive 8-12 mCi of \[F-18\]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.

Treatment:

Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)

Drug: [68Ga]PSMA

Diagnostic Test: PET/CT

[Ga-68]PSMA

Description:

Patients will receive up to 6 mCi of \[Ga-68\]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging

Treatment:

Drug: Flourine-18 [F-18] Sodium Fluoride (NaF)

Drug: [68Ga]PSMA

Diagnostic Test: PET/CT