Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

32

Study ID:

NCT05527483

Recruitment Status:

Completed

Sponsor:

University Hospitals Cleveland Medical Center

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There is 1 Location for this study

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Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

32

Study ID:

NCT05527483

Recruitment Status:

Completed

Sponsor:


University Hospitals Cleveland Medical Center

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