Prostate CancerNCT05002465
Clinical Use of 68Ga PSMA-11 PET/CT in Diagnosing, Staging and Restaging Prostate Cancer
A study testing 68Ga-PSMA-11 and Positron Emission Tomography/Computed Tomography in people with Prostate Cancer and Prostate Cancer Metastatic, run by Dana Mathews at 1 site in United States.
Trial summary
The purpose of this protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Recurrent
- What is being tested?
- 68Ga-PSMA-11 and Positron Emission Tomography/Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- One of the following:
- Patients with suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
- Patients with suspected metastasis who are candidates for initial definitive therapy.
- Patients with metastatic prostate cancer, for whom Lutetium-177 vipivotide tetraxetan PSMA-directed therapy is indicated.
- Patients must be able to lie still for approximately 20 - 40 minutes for the PET/CT scans.
- Patients must be deemed medically stable by their treating physician.
- Patients must have the ability and willingness to sign a written informed consent.
Who cannot join
- Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (> 225 kilograms or 500 pounds).
- Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11.
- Patients must not be claustrophobic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Use of 68Ga Prostate Specific Membrane Antigen-11 Positron Emission Tomography With Computed Tomography in Diagnosing, Staging and Restaging Prostate Cancer
The purpose of this protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Extensive research has shown that 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care usually used in staging and restaging prostate cancer.
Read the detailed description
68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care of computed tomography (CT), magnetic resonance imaging (MRI), and bone scintigraphy usually used in staging and restaging prostate cancer. Furthermore, 68Ga PSMA-11 PET/CT offers a higher detection rate of primary and metastatic prostate cancer compared to other available radiotracers used for prostate cancer. It additionally offers enhanced imaging characteristics of greater sensitivity at lower prostate specific antigen (PSA) values and higher target to background ratios than currently available radiotracers. For these reasons, we feel that expanded access to 68Ga PSMA-11 offers better patient care at comparable cost to standard imaging.
The population to be treated consists of men in whom metastatic or recurrent prostate cancer is suspected. Patients will be recruited primarily from the clinical practices of the University of Texas Southwestern Medical Center (UTSW) and Parkland Health and Hospital System. Additional patients may be referred for recruitment from physicians outside UTSW.
Each patient will receive an IV injection of 68Ga PSMA-11 as a bolus intravenous injection. Depending on patient medical history and Radiology physician preference, the patient may also be injected with 20 milligrams (mg) of furosemide to encourage urination, and the patient will void immediately prior to getting on the scan table. Patients will be scanned on a PET/CT scanner. The patient will be positioned with arms elevated above the head.
- Being tested
- 68Ga-PSMA-11, Positron Emission Tomography/Computed Tomography
- Keywords
- Gallium-68, PSMA-11, 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-PSMA-11Drug
Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed TomographyProcedure or surgery
Also called PET/CT
PET/CT scan after 68Ga PSMA-11 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Dana Mathews
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dana Mathews, University of Texas Southwestern Medical Center
- Investigators
- Orhan K Oz, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002465
- Sponsor's protocol ID
- STU-2021-0291
- Status last verified
- Sep 2023
- First submitted
- 27 Jul 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Use of 68Ga Prostate Specific Membrane Antigen-11 Positron Emission Tomography With Computed Tomography in Diagnosing, Staging and Restaging Prostate Cancer
- ClinicalTrials.gov ID
- NCT05002465
- Acronym / sponsor ID
- STU-2021-0291
- Keywords
- Gallium-68, PSMA-11, PET/CT
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Dana MathewsUniversity, hospital or other
- First posted
- 12 Aug 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 protocol is to provide 68Ga Prostate Specific Membrane Antigen-11 (68Ga PSMA-11) for clinical use in the diagnosis, staging and restaging of prostate cancer using Positron Emission Tomography with Computed Tomography (PET/CT) prior to its full local Federal Drug Administration (FDA) approval. Extensive research has shown that 68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care usually used in staging and restaging prostate cancer.
Detailed description
68Ga PSMA-11 PET/CT offers higher detection rate of metastatic disease in prostate cancer than the current standard of care of computed tomography (CT), magnetic resonance imaging (MRI), and bone scintigraphy usually used in staging and restaging prostate cancer. Furthermore, 68Ga PSMA-11 PET/CT offers a higher detection rate of primary and metastatic prostate cancer compared to other available radiotracers used for prostate cancer. It additionally offers enhanced imaging characteristics of greater sensitivity at lower prostate specific antigen (PSA) values and higher target to background ratios than currently available radiotracers. For these reasons, we feel that expanded access to 68Ga PSMA-11 offers better patient care at comparable cost to standard imaging.
The population to be treated consists of men in whom metastatic or recurrent prostate cancer is suspected. Patients will be recruited primarily from the clinical practices of the University of Texas Southwestern Medical Center (UTSW) and Parkland Health and Hospital System. Additional patients may be referred for recruitment from physicians outside UTSW.
Each patient will receive an IV injection of 68Ga PSMA-11 as a bolus intravenous injection. Depending on patient medical history and Radiology physician preference, the patient may also be injected with 20 milligrams (mg) of furosemide to encourage urination, and the patient will void immediately prior to getting on the scan table. Patients will be scanned on a PET/CT scanner. The patient will be positioned with arms elevated above the head.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- One of the following:
- Patients must be able to lie still for approximately 20 - 40 minutes for the PET/CT scans.
- Patients must be deemed medically stable by their treating physician.
- Patients must have the ability and willingness to sign a written informed consent.
Key exclusion criteria (3 listed)
- Patients must not weigh more than the maximum weight limit for the PET/CT scanner table (> 225 kilograms or 500 pounds).
- Patients must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11.
- Patients must not be claustrophobic.
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-PSMA-11Injection of 68Ga PSMA-11 | Drug | – |
| Positron Emission Tomography/Computed TomographyAlso: PET/CTPET/CT scan after 68Ga PSMA-11 injection | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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.
Orhan K Oz, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-PSMA-11 and Positron Emission Tomography/Computed Tomography in people with Prostate Cancer and Prostate Cancer Metastatic, run by Dana Mathews 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 7 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: status not confirmed, as of the sponsor's last update on 11 Sep 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?
Results are not available in the source record.
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.
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 11 Sep 2023.