Clinical trial NCT05527483: Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
Official title: Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Bone Metastasis
PET/CT
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Members of all races and ethnic groups are eligible for this trial. Due to the nature of the disease, only people being diagnosed with prostate cancer are eligible.

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.


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

Primary outcomes:
measure: Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Focally increased [Ga-68]PSMA uptake as measured by PET/CT
timeFrame: Up to 90 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: UH, Cleveland Medical Center
name: Robert Jones, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UH, Cleveland Medical Center
name: Norbert Avril, M.D.
role: PRINCIPAL_INVESTIGATOR
References: