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Completed

NCT Number: NCT04867603

Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions

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.

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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

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

[Ga-68]PSMA

Drug

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

Device

PET/CT imaging procedure

Primary outcomes

  1. True positive rate

    Time frame: During scan, up to 35 minutes

    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

  2. False positive rate

    Time frame: During scan, up to 35 minutes

    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

  3. True negative rate

    Time frame: During scan, up to 35 minutes

    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

  4. False negative negative rate

    Time frame: During scan, up to 35 minutes

    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

  5. Sensitivity

    Time frame: During scan, up to 35 minutes

    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

  6. Specificity

    Time frame: During scan, up to 35 minutes

    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

  7. Positive predictive value (PPV)

    Time frame: During scan, up to 35 minutes

    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

  8. Negative predictive value (NPV)

    Time frame: During scan, up to 35 minutes

    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

  9. Proportion of prostate lesions determined to be cancer determined by [Ga-68]PSMA compared to histopathology

    Time frame: During scan, up to 35 minutes

    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.

Secondary outcomes

  1. Determination of prostate lesion aggressiveness using Gleason scores

    Time frame: During scan, up to 35 minutes

    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)

  2. Determination of prostate lesion aggressiveness using prostate grading system scores

    Time frame: During scan, up to 35 minutes

    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

  3. Average pre-test PSA level

    Time frame: During scan, up to 35 minutes

    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.

  4. Proportion of metastatic lesions identified by digital PET/CT using [Ga-68]PSMA compared to reference

    Time frame: During scan, up to 35 minutes

    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.

Other outcomes

  1. Optimized image reconstruction parameters - Voxel size

    Time frame: During scan, up to 35 minutes

    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

  2. Optimized image reconstruction parameters - Image quality

    Time frame: During scan, up to 35 minutes

    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

  3. Optimized acquisition and reconstruction parameters of digital PET - Image quality

    Time frame: During scan, up to 35 minutes

    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

  4. Optimized acquisition and reconstruction parameters of digital PET - Iterations and subsets

    Time frame: During scan, up to 35 minutes

    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.

Sponsors and collaborators

Lead sponsor

Norbert Avril, M.D.

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 30, 2021
Registry last updated
Dec 19, 2023

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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