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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527483
• Other study ID #: STUDY20220121
• Status: Completed
• Start date: April 21, 2022
• Est. completion date: October 10, 2022

Study information

• Verified date: May 2024
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• Flourine-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 Test:
• PET/CT
Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Focally increased [Ga-68]PSMA uptake as measured by PET/CT		Up to 90 minutes