Clinical trial NCT04867603: Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
Official title: Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of participants who are at least 18 years old with a clinical suspicion of prostate cancer. Patients are referred from the Urology Institute within the University Hospitals Health System.

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 characterization of prostate abnormalities.

Detailed description: Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored for likelihood for malignancy using the PI-RADS version 2.1 criteria. Those with PI-RADS 3, 4 or 5 lesions or those with PI-RADS 1 or 2 lesions with clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) will be included on study. Only those receiving care at University Hospitals Cleveland Medical Center will be included into the study.

This study is to evaluate (\[Ga-68\]PSMA) for characterization of prostate abnormalities. For imaging, an FDA approved imaging technology, digital Positron Emission Tomography (PET/CT) will be used. The study team would like to know if digital PET/CT using \[Ga-68\]PSMA provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. \[Ga-68\]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen (PSA), which is overexpressed in prostate cancer. \[Ga-68\]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA). However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.

Eligibility criteria: Inclusion Criteria:

* Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
* Able to tolerate PET/CT scans
* Informed consent must be given and signed

Exclusion Criteria:

* Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
* Known allergy against Ga-68 PSMA
* Prior prostate biopsy within the last 2 weeks

Primary outcomes:
measure: True positive rate
timeFrame: During scan, up to 35 minutes
measure: False positive rate
timeFrame: During scan, up to 35 minutes
measure: True negative rate
timeFrame: During scan, up to 35 minutes
measure: False negative negative rate
timeFrame: During scan, up to 35 minutes
measure: Sensitivity
timeFrame: During scan, up to 35 minutes
measure: Specificity
timeFrame: During scan, up to 35 minutes
measure: Positive predictive value (PPV)
timeFrame: During scan, up to 35 minutes
measure: Negative predictive value (NPV)
timeFrame: During scan, up to 35 minutes
measure: Proportion of prostate lesions determined to be cancer determined by [Ga-68]PSMA compared to histopathology
timeFrame: During scan, up to 35 minutes
Secondary outcomes:
measure: Determination of prostate lesion aggressiveness using Gleason scores
timeFrame: During scan, up to 35 minutes
measure: Determination of prostate lesion aggressiveness using prostate grading system scores
timeFrame: During scan, up to 35 minutes
measure: Average pre-test PSA level
timeFrame: During scan, up to 35 minutes
measure: Proportion of metastatic lesions identified by digital PET/CT using [Ga-68]PSMA compared to reference
timeFrame: During scan, up to 35 minutes
Other outcomes:
measure: Optimized image reconstruction parameters - Voxel size
timeFrame: During scan, up to 35 minutes
measure: Optimized image reconstruction parameters - Image quality
timeFrame: During scan, up to 35 minutes
measure: Optimized acquisition and reconstruction parameters of digital PET - Image quality
timeFrame: During scan, up to 35 minutes
measure: Optimized acquisition and reconstruction parameters of digital PET - Iterations and subsets
timeFrame: During scan, up to 35 minutes
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Norbert Avril, MD
role: PRINCIPAL_INVESTIGATOR
References: