An observational study in Prostate Cancer, sponsored by Norbert Avril, M.D.. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by Norbert Avril, M.D. · Observational
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.
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 16 is below the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.
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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.
Exclusion Criteria:
Following prostate Standard of Care MRI, eligible participants will receive a single injection of \[Ga-68\]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.
Drug: [Ga-68]PSMA · Device: PET/CT imaging
The injectable activity will be a maximum of 210 MBq (6.0 mCi) \[Ga-68\]PSMA at the time of injection and is administered to subjects by intravenous injection.
PET/CT imaging procedure
True positive rate
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by true-positive rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
False positive rate
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by false-positive rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
True negative rate
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by true negative rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
False negative negative rate
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by false negative rate. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
Sensitivity
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by sensitivity. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
Specificity
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by specificity. The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
Positive predictive value (PPV)
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by (PPV). The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
Negative predictive value (NPV)
Diagnostic performance of digital PET/CT using \[Ga-68\]PSMA for characterization of prostate lesions, as measured by (NPV). The uptake of \[Ga-68\]PSMA within the prostate gland will be visually assessed and compared to surrounding tracer uptake within the prostate gland. The majority of participants will subsequently undergo prostate biopsy as part of routine clinical work-up. Subsequent histopathology will be used as the reference standard. If participants do not undergo prostate biopsy, participant follow-up (PSA level, prostate imaging, or later biopsy) will be used as reference standard
Time frame: During scan, up to 35 minutes
Proportion of prostate lesions determined to be cancer determined by [Ga-68]PSMA compared to histopathology
Quantitative data collected from PET biomarker (\[Ga-68\]PSMA) uptake will be used to analyze prostate lesions for differentiation between benign prostate changes and prostate cancer. Differentiation prostate lesion by PET biomarker will be compared to histology reference standard.
Time frame: During scan, up to 35 minutes
Determination of prostate lesion aggressiveness using Gleason scores
Uptake of (\[Ga-68\]PSMA) will be compared with the Gleason score, which is a grading system used to determine the aggressiveness of prostate cancer. Scores range from 2 to 10, with higher scores indicating worse outcomes (more likely that the cancer will grow and metastasize)
Time frame: During scan, up to 35 minutes
Determination of prostate lesion aggressiveness using prostate grading system scores
Uptake of (\[Ga-68\]PSMA) wil be compared with the prostate grading system score, which is an extension of the current Gleason grading scale for determining the stage and aggressiveness of prostate cancer. This system is designed to provide a simplified and more accurate grading stratification system than the current Gleason Score. Scores range from 1 to 5, with higher scores indicating worse outcomes
Time frame: During scan, up to 35 minutes
Average pre-test PSA level
Average pre-test PSA level will be measured and reported. Ability of digital PET/CT using \[Ga-68\]PSMA uptake to identify malignant prostate lesions will be explored by plotting PSA levels against diagnostic performance of PET/CT using \[Ga-68\]PSMA, with histopathology serving as the reference standard.
Time frame: During scan, up to 35 minutes
Proportion of metastatic lesions identified by digital PET/CT using [Ga-68]PSMA compared to reference
Focally increased \[Ga-68\]PSMA uptake within the torso PET images will be compared with standard of care clinical imaging to verify the presence of metastatic lesions. In addition, patient follow up and histopathology will be used as reference if available.
Time frame: During scan, up to 35 minutes
Optimized image reconstruction parameters - Voxel size
The acquired datasets from digital PET/CT using \[Ga-68\]PSMA will be reconstructed in different voxel sizes and by using dedicated reconstruction parameters affecting the noise levels of the images. Optimized image reconstruction parameters will be identified, including "voxel size" and "image quality" - Voxel size: 4x4x4mm, 2x2x2mm, 1x1x1mm
Time frame: During scan, up to 35 minutes
Optimized image reconstruction parameters - Image quality
The acquired datasets from digital PET/CT using \[Ga-68\]PSMA will be reconstructed in different voxel sizes and by using dedicated reconstruction parameters affecting the noise levels of the images. Optimized image reconstruction parameters will be identified, including "voxel size" and "image quality" - Image quality, assessed via visual analysis focused on the separation of anatomical structures (.e.g. delineation of the pelvis) and abnormal findings, e.g. increased tracer uptake within the prostate gland
Time frame: During scan, up to 35 minutes
Optimized acquisition and reconstruction parameters of digital PET - Image quality
Acquired PET/CT data sets will be reconstructed using different algorithms including respiratory and cardiac motion. The impact of variation in acquisition and reconstruction parameters on quantification of PET images will be assessed as well, Including "image quality" and "iterations and subsets" - Image quality, assessed via visual analysis focused on the separation of anatomical structures (.e.g. delineation of the pelvis) and abnormal findings, e.g. increased tracer uptake within the prostate glan
Time frame: During scan, up to 35 minutes
Optimized acquisition and reconstruction parameters of digital PET - Iterations and subsets
Acquired PET/CT data sets will be reconstructed using different algorithms including respiratory and cardiac motion. The impact of variation in acquisition and reconstruction parameters on quantification of PET images will be assessed as well, Including "image quality" and "iterations and subsets" - Iterations and subsets are part of the Iterative Reconstruction used for PET image reconstruction. Ordered subsets methods group projection data into an ordered sequence of subsets (or blocks). An iteration of ordered subsets EM is defined as a single pass through all the subsets, in each subset using the current estimate to initialize application of EM with that data subset.
Time frame: During scan, up to 35 minutes
Plan to share: No — No current plan to share data
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