Prostate CancerPhase 3NCT05678322
Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy
A Phase 3 study testing 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent and PET MRI Imaging in people with Prostate Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA > 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidence of disease… Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent and PET MRI Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2023to Nov 2026
- Phase
- Phase 3
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients will include all men between age 18 -100 years old,-that have had RP, at the first point in time the PSA > 0.2 ng/ml.
Who cannot join
- Any contraindication for MRI imaging.
- Prior allergic reaction to rhPSMA-7.3 (18F).
- Patient refuses rhPSMA-7.3 (18F) PET/MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Smilow Comprehensive Prostate Cancer Center
New York, New York, 10016
About this study
All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA > 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidence of disease recurrence. Early identification of the site(s) of disease recurrence enables early salvage intervention. Men will be eligible for the study at the point in time their post-prostatectomy PSA level first becomes >0.2 ng/ml. Only those patients with rhPSMA-7.3 (18F) identifiable disease (local, nodal or systemic) will be offered salvage intervention per standard of care. All patients with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA is > 0,5 ng/ml or one year after the initial PET study. The salvage interventions will be at the discretion of the investigator. The study will compare the diagnostic yield of the first and second rhPSMA-7.3 (18F) studies.
- Conditions
- Prostate Cancer
- Being tested
- 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent, PET MRI 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.
18F-Labeled Positron Emission Tomography (PET) Diagnostic AgentDrug
Also called rhPSMA-7.3 (18F)
Under development for the diagnosis of prostate cancer by Blue Earth Diagnostics. rhPSMA-7.3 (18F) will be administered intravenously as a single-dose injection. The molecular structure of the drug substance comprises a prostate-specific membrane antigen (PSMA) binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor moiety and a gallium chelator complex.
PET MRI ImagingDevice
rhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PSA > 0.2 ng/ml following Radical Prostatectomy | Experimental | Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator. Receives: Drug: 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent; Device: PET MRI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive PCa Screens at Baseline
This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan.
Measured: Baseline
Positive PCa Screens at Second Scan Visit
This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the second rhPSMA-7.3 (18F) scan.
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start31 Jan 2023
- Primary completion8 May 2025
- Study completionNov 2026 (estimated)
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.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor
- Investigators
- Herbert Lepor, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678322
- Sponsor's protocol ID
- 22-00547
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2022
- Last updated
- 25 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lepor H, Vargas HA, Tafa M, Wysock JS, Tan WP, Nayan M. Detection rate of PSMA PET MRI (18 F-Flotufolastat) at the onset of biochemical recurrence following radical prostatectomy. EJNMMI Rep. 2026 Oct 9;10(1):41. doi: 10.1186/s41824-026-00325-4.
PubMed 42850466
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT05678322
- Acronym / sponsor ID
- 22-00547
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Posted 25 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA > 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidence of disease recurrence. Early identification of the site(s) of disease recurrence enables early salvage intervention. Men will be eligible for the study at the point in time their post-prostatectomy PSA level first becomes >0.2 ng/ml. Only those patients with rhPSMA-7.3 (18F) identifiable disease (local, nodal or systemic) will be offered salvage intervention per standard of care. All patients with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA is > 0,5 ng/ml or one year after the initial PET study. The salvage interventions will be at the discretion of the investigator. The study will compare the diagnostic yield of the first and second rhPSMA-7.3 (18F) studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PSA > 0.2 ng/ml following Radical Prostatectomy | Experimental | Drug: 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent, Device: PET MRI ImagingMen will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA >0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible patients will include all men between age 18 -100 years old,-that have had RP, at the first point in time the PSA > 0.2 ng/ml.
Key exclusion criteria (3 listed)
- Any contraindication for MRI imaging.
- Prior allergic reaction to rhPSMA-7.3 (18F).
- Patient refuses rhPSMA-7.3 (18F) PET/MRI.
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 |
|---|---|---|
| 18F-Labeled Positron Emission Tomography (PET) Diagnostic AgentAlso: rhPSMA-7.3 (18F)Under development for the diagnosis of prostate cancer by Blue Earth Diagnostics. rhPSMA-7.3 (18F) will be administered intravenously as a single-dose injection. The molecular structure of the drug substance comprises a prostate-specific membrane antigen (PSMA) binding motif, a peptide spacer, an 18F-radiolabeled silicon fluoride acceptor moiety and a gallium chelator complex. | Drug | Patients with PSA > 0.2 ng/ml following Radical Prostatectomy |
| PET MRI ImagingrhPSMA-7.3 (18F) PET MRI imaging will be conducted once at baseline and a second time within one year of the initial scan. | Device | Patients with PSA > 0.2 ng/ml following Radical Prostatectomy |
Primary outcome
Positive PCa Screens at Baseline
Time frame: Baseline
This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the baseline rhPSMA-7.3 (18F) scan.
Positive PCa Screens at Second Scan Visit
Time frame: Up to Month 24
This measurement will calculate the number of participants who screen positive for prostate cancer (PCa) at the second rhPSMA-7.3 (18F) scan.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42850466Lepor H, Vargas HA, Tafa M, Wysock JS, Tan WP, Nayan M. Detection rate of PSMA PET MRI (18 F-Flotufolastat) at the onset of biochemical recurrence following radical prostatectomy. EJNMMI Rep. 2026 Oct 9;10(1):41. doi: 10.1186/s41824-026-00325-4.
- 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.
Herbert Lepor, MD principal investigator
NYU Langone 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 3 study testing 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent and PET MRI Imaging in people with Prostate Cancer, run by NYU Langone Health 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 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Mar 2026). 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?
Positive PCa Screens at Baseline (time frame: Baseline). 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 NCT05678322, 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 25 Mar 2026.