Prostate CancerNCT05527483
Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
An observational study of Prostate Cancer, run by University Hospitals Cleveland Medical Center 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 detection of bone metastasis in patients with prostate cancer. 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?
- [68Ga]PSMA, Flourine-18 [F-18] Sodium Fluoride (NaF) and PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 10 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: Members of all races and ethnic groups are eligible for this trial. Due to the nature of the disease, only people being diagnosed with prostate cancer are eligible.
Who may be able to join
- 1) Patients must have a history of prostate cancer
- 2) Patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging.
- 3) Patients ≥ 18 years old
- 4) Patients able to tolerate PET/CT scans
- 5) Informed written consent must be given and signed
Who cannot join
- 1. Subjects who do not meet the noted inclusion criteria
- 2. Patients < 18 years old
- 3. Subjects who refuse to give or are unable to sign the informed consent
- 4. Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- 5. Patients with a known allergy against Ga-68 PSMA or F-18 NaF
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
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 detection of bone metastasis in patients with prostate cancer.
For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information about the extent of bone metastases.
Therefore, the investigators will compare[Ga-68]PSMA PET/CT with Flourine-18 [F-18] Sodium Fluoride (NaF), which is a high resolution bone scan. [F-18]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.[Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.
- Conditions
- Prostate Cancer
- Being tested
- [68Ga]PSMA, Flourine-18 [F-18] Sodium Fluoride (NaF), PET/CT
- Keywords
- Bone Metastasis, PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]PSMADrug
Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging
Flourine-18 [F-18] Sodium Fluoride (NaF)Drug
Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging.
PET/CTDiagnostic test
Patients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT
| Study group | Role | What they receive |
|---|---|---|
| [F-18]NaF | Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging. Receives: Drug: [68Ga]PSMA; Drug: Flourine-18 [F-18] Sodium Fluoride (NaF); Diagnostic Test: PET/CT | |
| [Ga-68]PSMA | Patients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging Receives: Drug: [68Ga]PSMA; Drug: Flourine-18 [F-18] Sodium Fluoride (NaF); Diagnostic Test: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
Classified using a 5-point score with one being definitely metastatic and five being definitely benign
Measured: Up to 90 minutes
Secondary outcomes (1)
Focally increased [Ga-68]PSMA uptake as measured by PET/CT
Measured: Up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start21 Apr 2022
- Primary completion10 Oct 2022
- Study completion10 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.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert Avril, University Hospitals Cleveland Medical Center
- Investigators
- Robert Jones, M.D., Principal investigator, UH, Cleveland Medical CenterNorbert Avril, M.D., Principal investigator, UH, Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527483
- Sponsor's protocol ID
- STUDY20220121
- Status last verified
- May 2024
- First submitted
- 31 Aug 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital PET/CT Using [Ga-68]PSMA vs. [F-18]NaF for Evaluation of Osseous Metastatic Involvement in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT05527483
- Acronym / sponsor ID
- STUDY20220121
- Conditions
- Prostate Cancer
- Keywords
- Bone Metastasis, PET/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 2 Sep 2022 (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 detection of bone metastasis in patients with prostate cancer.
For imaging the investigators will use a FDA approved imaging technology, digital Positron Emission Tomography (PET/CT). The investigators would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information about the extent of bone metastases.
Therefore, the investigators will compare[Ga-68]PSMA PET/CT with Flourine-18 [F-18] Sodium Fluoride (NaF), which is a high resolution bone scan. [F-18]NaF is FDA approved and the reference standard for evaluating the presence of bone metastases.[Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen, which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA) at University Hospitals. 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
- 2
| Arm | Type | Receives |
|---|---|---|
| [F-18]NaF | – | Drug: [68Ga]PSMA, Drug: Flourine-18 [F-18] Sodium Fluoride (NaF), Diagnostic Test: PET/CTPatients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging. |
| [Ga-68]PSMA | – | Drug: [68Ga]PSMA, Drug: Flourine-18 [F-18] Sodium Fluoride (NaF), Diagnostic Test: PET/CTPatients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Members of all races and ethnic groups are eligible for this trial. Due to the nature of the disease, only people being diagnosed with prostate cancer are eligible.
Key inclusion criteria (5 listed)
- 1) Patients must have a history of prostate cancer
- 2) Patients have known or highly suspected osseous metastatic involvement defined by the referring physician based on clinical history and/or findings from standard of care imaging.
- 3) Patients ≥ 18 years old
- 4) Patients able to tolerate PET/CT scans
- 5) Informed written consent must be given and signed
Key exclusion criteria (5 listed)
- 1. Subjects who do not meet the noted inclusion criteria
- 2. Patients < 18 years old
- 3. Subjects who refuse to give or are unable to sign the informed consent
- 4. Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
- 5. Patients with a known allergy against Ga-68 PSMA or F-18 NaF
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 |
|---|---|---|
| [68Ga]PSMAPatients will receive up to 6 mCi of [Ga-68]PSMA delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging | Drug | [F-18]NaF, [Ga-68]PSMA |
| Flourine-18 [F-18] Sodium Fluoride (NaF)Patients will receive 8-12 mCi of [F-18]NaF delivered as an intravenous (IV) bolus injection, followed by digital PET/CT imaging. | Drug | [F-18]NaF, [Ga-68]PSMA |
| PET/CTPatients will receive [68Ga]PSMA with a PET/CT and Flourine-18 [F-18] Sodium Fluoride (NaF) with a PET/CT | Diagnostic test | [F-18]NaF, [Ga-68]PSMA |
Primary outcome
Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis
Time frame: Up to 90 minutes
Classified using a 5-point score with one being definitely metastatic and five being definitely benign
1 secondary outcome
Focally increased [Ga-68]PSMA uptake as measured by PET/CT
Time frame: Up to 90 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 16 May 2024.
- Individual participant dataSharing planned: No
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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.
Robert Jones, M.D. principal investigator
UH, Cleveland Medical Center
Norbert Avril, M.D. principal investigator
UH, Cleveland Medical 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 University Hospitals Cleveland Medical Center 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 5 inclusion and 5 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 16 May 2024. 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?
Uptake of [Ga-68]PSMA as measured by lesion by lesion analysis (time frame: Up to 90 minutes). 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 16 May 2024.