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Completed

NCT Number: NCT05527483

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[68Ga]PSMA

Drug

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)

Drug

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

PET/CT

Diagnostic Test

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

Primary outcomes

  1. Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis

    Time frame: Up to 90 minutes

    Classified using a 5-point score with one being definitely metastatic and five being definitely benign

Secondary outcomes

  1. Focally increased [Ga-68]PSMA uptake as measured by PET/CT

    Time frame: Up to 90 minutes

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2022
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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