Prostate CancerNCT04867603
Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
An observational study of Prostate Cancer, run by Norbert Avril, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- [Ga-68]PSMA and PET/CT imaging
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 3 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- [Ga-68]PSMA, PET/CT imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Ga-68]PSMADrug
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 imagingDevice
PET/CT imaging procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [Ga-68]PSMA; Device: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: During scan, up to 35 minutes
Secondary outcomes (4)
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: During scan, up to 35 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start29 Jun 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norbert Avril, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Norbert Avril, M.D., Case Comprehensive Cancer Center
- Investigators
- Norbert Avril, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867603
- Sponsor's protocol ID
- CASE1821
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: No current plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions
- ClinicalTrials.gov ID
- NCT04867603
- Acronym / sponsor ID
- CASE1821
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norbert Avril, M.D.University, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital PET/CT using [Ga-68]PSMA | – | Drug: [Ga-68]PSMA, Device: PET/CT imagingFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [Ga-68]PSMAThe 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. | Drug | Digital PET/CT using [Ga-68]PSMA |
| PET/CT imagingPET/CT imaging procedure | Device | Digital PET/CT using [Ga-68]PSMA |
Primary outcome
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
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
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
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
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
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
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
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
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.
4 secondary outcomes
Determination of prostate lesion aggressiveness using Gleason scores
Time frame: During scan, up to 35 minutes
Determination of prostate lesion aggressiveness using prostate grading system scores
Time frame: During scan, up to 35 minutes
Average pre-test PSA level
Time frame: During scan, up to 35 minutes
Proportion of metastatic lesions identified by digital PET/CT using [Ga-68]PSMA compared to reference
Time frame: During scan, up to 35 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No. No current plan to share data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Avril, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Norbert Avril, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True positive rate (time frame: During scan, up to 35 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023; AzTrials last refreshed its copy on 3 Nov 2026.