Prostate CancerPhase 2NCT04179968
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
A Phase 2 study testing 68Ga PSMA-11 injection 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
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate… 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
- What is being tested?
- 68Ga PSMA-11 injection and Positron Emission Tomography/Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to 15 Jul 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
- Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
- In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
- Patients must be scheduled for biopsy or radical prostatectomy
- Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
- Patients must be medically stable as judged by the patient's physician
- Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
- Patients who have had a prior biopsy for prostate cancer cannot participate in the study
- Patients who have been treated for cancers other than skin cancers
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
- Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
- Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies
Trial locations and contacts
1 site in 1 country.
About this study
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).
Read the detailed description
This study is designed to evaluate the added value of 68Ga PSMA-11 PET/CT for detection of additional primary prostate cancer lesions compared to multiparametric magnetic resonance imaging (mpMRI) in a group of patients with elevated PI-RADS scores and PSA. We propose that the addition of early dynamic 68Ga PSMA-11 PET/CT imaging to the more usual delayed imaging will enhance detection of primary lesions and additional lesions not detected on the mpMRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of uptake in the prostate gland. It is possible that even in the absence of focal uptake, hyperemia of the gland could indicate the presence of an occult primary.
A second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in this same group of patients in detecting metastatic disease at initial staging in comparison with current standard of care imaging such as computed tomography (CT) and magnetic resonance imaging (MRI).
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Being tested
- 68Ga PSMA-11 injection, Positron Emission Tomography/Computed Tomography
- Keywords
- PET/CT, prostate cancer, Gallium-68, PSMA-11
- 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-11 injectionDrug
Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed TomographyProcedure or surgery
Also called PET/CT
PET/CT scan after 68Ga PSMA-11 injection
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected prostate cancer | Experimental | Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy Receives: Drug: 68Ga PSMA-11 injection; Procedure: Positron Emission Tomography/Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
Measured: During PET/CT imaging, up to 2 hours
Number of Primary Prostate Lesions Detected by mpMRI
Number of primary prostate lesions will be detected by using mpMRI.
Measured: During mpMRI, up to 2 hours
Secondary outcomes (2)
Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT
Number of sites of metastatic prostate lesions will be detected using 68Ga-PSMA-11 PET/CT. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
Measured: During PET/CT imaging, up to 2 hours
Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)
Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).
Measured: During CT/MRI imaging, up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start27 Jan 2020
- Primary completion9 Sep 2021
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Unblinded, single arm imaging study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT04179968
- Sponsor's protocol ID
- STU-2019-1198
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2019
- Last updated
- 20 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parrott D, Yuan Q, Pinho D, Xi Y, Costa DN, De Leon AD, Dakanali M, Sun X, Oz OK, Bowen S, Rofsky NM, Mathews D, Pedrosa I. Characterization of suspicious prostate lesions at multiparametric MRI with dynamic 68 Ga-Gozetotide PET/CT. EJNMMI Rep. 2025 Oct 13;9(1):35. doi: 10.1186/s41824-025-00268-2.
PubMed 41077599
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT04179968
- Acronym / sponsor ID
- STU-2019-1198
- Conditions
- Prostate Cancer, Prostate Cancer Metastatic
- Keywords
- PET/CT, prostate cancer, Gallium-68, PSMA-11
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dana MathewsUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 20 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To goal of this research is to assess the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to increase diagnostic accuracy in localizing primary and metastatic lesions in patients with suspected prostate cancer and elevated Prostate Imaging Reporting and Data System (PI-RADS) scores and Prostate-Specific Antigen (PSA).
Detailed description
This study is designed to evaluate the added value of 68Ga PSMA-11 PET/CT for detection of additional primary prostate cancer lesions compared to multiparametric magnetic resonance imaging (mpMRI) in a group of patients with elevated PI-RADS scores and PSA. We propose that the addition of early dynamic 68Ga PSMA-11 PET/CT imaging to the more usual delayed imaging will enhance detection of primary lesions and additional lesions not detected on the mpMRI. In addition, the dynamic imaging will allow us to evaluate the kinetics of uptake in the prostate gland. It is possible that even in the absence of focal uptake, hyperemia of the gland could indicate the presence of an occult primary.
A second purpose of this research is to examine the value of 68Ga PSMA-11 PET/CT in this same group of patients in detecting metastatic disease at initial staging in comparison with current standard of care imaging such as computed tomography (CT) and magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Unblinded, single arm imaging study
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected prostate cancer | Experimental | Drug: 68Ga PSMA-11 injection, Procedure: Positron Emission Tomography/Computed TomographyPatients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
- Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
- In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
- Patients must be scheduled for biopsy or radical prostatectomy
- Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
Key exclusion criteria (7 listed)
- Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
- Patients who have had a prior biopsy for prostate cancer cannot participate in the study
- Patients who have been treated for cancers other than skin cancers
- Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
- Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
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-11 injectionInjection of 68Ga PSMA-11 | Drug | Patients with suspected prostate cancer |
| Positron Emission Tomography/Computed TomographyAlso: PET/CTPET/CT scan after 68Ga PSMA-11 injection | Procedure or surgery | Patients with suspected prostate cancer |
Primary outcome
Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
Time frame: During PET/CT imaging, up to 2 hours
Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
Number of Primary Prostate Lesions Detected by mpMRI
Time frame: During mpMRI, up to 2 hours
Number of primary prostate lesions will be detected by using mpMRI.
2 secondary outcomes
Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT
Time frame: During PET/CT imaging, up to 2 hours
Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)
Time frame: During CT/MRI imaging, up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41077599Parrott D, Yuan Q, Pinho D, Xi Y, Costa DN, De Leon AD, Dakanali M, Sun X, Oz OK, Bowen S, Rofsky NM, Mathews D, Pedrosa I. Characterization of suspicious prostate lesions at multiparametric MRI with dynamic 68 Ga-Gozetotide PET/CT. EJNMMI Rep. 2025 Oct 13;9(1):35. doi: 10.1186/s41824-025-00268-2.
- 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.
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 Phase 2 study testing 68Ga PSMA-11 injection 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 8 inclusion and 7 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 20 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging (time frame: During PET/CT imaging, up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179968, which also lists 1 linked publication.
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 20 Mar 2023.