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

NCT04867603 | Completed FDA Drug FDA Device

• 1 other identifier: CASE1821
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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

  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

  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

  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

  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

  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

  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.

  During scan, up to 35 minutes

Secondary Outcomes (4)

• Determination of prostate lesion aggressiveness using Gleason scores

  During scan, up to 35 minutes

• Determination of prostate lesion aggressiveness using prostate grading system scores

  During scan, up to 35 minutes

• Average pre-test PSA level

  During scan, up to 35 minutes

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

  During scan, up to 35 minutes

Other Outcomes (4)

• Optimized image reconstruction parameters - Voxel size

  During scan, up to 35 minutes

• Optimized image reconstruction parameters - Image quality

  During scan, up to 35 minutes

• Optimized acquisition and reconstruction parameters of digital PET - Image quality

  During scan, up to 35 minutes

Study Arms (1)

Digital PET/CT using [Ga-68]PSMA

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

Interventions

[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.

Digital PET/CT using [Ga-68]PSMA

PET/CT imaging DEVICE

PET/CT imaging procedure

Digital PET/CT using [Ga-68]PSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norbert Avril, M.D.: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Norbert Avril, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: April 30, 2021
• Study Start: June 29, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)