Biochemically Recurrent Prostate CarcinomaEarly Phase 1NCT06813898
An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial
A Early Phase 1 study testing Computed Tomography, Electronic Health Record Review and Flotufolastat F-18 Gallium in people with Biochemically Recurrent Prostate Carcinoma and Prostate Adenocarcinoma, run by Northwestern University at 1 site in United States.
Trial summary
This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography [PET]/computed tomography [CT]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Biochemically Recurrent Prostate Carcinoma, Prostate Adenocarcinoma
- What is being tested?
- Computed Tomography, Electronic Health Record Review and Flotufolastat F-18 Gallium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2025to 1 Feb 2032
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy [i.e. salvage radiation])
- Men must have biochemical recurrence (defined as PSA >= 0.1ng/ml) after therapy
- PSA < 0.5ng/ml (within 90 days of enrollment)
- Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer
- Non-castrate testosterone (testosterone [T] > 50ng/dL) within 90 days of study entry
- Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
- Concurrent diseases and malignancies are permitted
Who cannot join
- Most recent PSA not between 0.1ng/ml and 0.5ng/ml
- Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T < 50ng/dl)
- Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Ashley E. Ross, 312-694-9001, ashley.ross@nm.org
Ashley E. Ross
About this study
Official title: ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging
This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography [PET]/computed tomography [CT]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine consensus detection rate by flotufolastat F-18 gallium (rhPSMA-7.3)-PET (POSLUMA) scan in men with recent negative non-POSLUMA PET prostate specific membrane antigen (PSMA) scans.
SECONDARY OBJECTIVES:
- Determine patient level verified detection rates (by histopathology or a surrogate standard of truth [second contemporaneous imaging, treatment response/change in subsequent imaging]).
II. Determine change in management plan based on POSLUMA scan (major / minor).
EXPLORATORY OBJECTIVE:
- Determine patient and patient disease characteristics consistent with a positive POSLUMA scan at prostate specific antigen (PSA) < 0.5ng/ml (i.e. pathological Gleason grade, PSA at scan, time to biochemical recurrence [BCR], prostate-specific antigen doubling time [PSADT]).
OUTLINE:
Patients receive rhPSMA-7.3 intravenously (IV) and undergo PET/CT 60 minutes later on day 1.
After completion of study intervention, patients are followed up at 14 days and then every 3 months for 2 years.
- Being tested
- Computed Tomography, Electronic Health Record Review, Flotufolastat F-18 Gallium, Positron Emission Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET/CT
Electronic Health Record ReviewOther
Ancillary studies
Flotufolastat F-18 GalliumDrug
Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (rhPSMA-7.3 PET/CT) | Experimental | Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1. Receives: Procedure: Computed Tomography; Other: Electronic Health Record Review; Drug: Flotufolastat F-18 Gallium; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consensus detection rate
Reads will be completed for the positron emission tomography (PET)/computed tomography (CT) by three trained radiologist blinded to each other's read. Uptake values of rhPSMA-7.3 (POSLUMA) in the prostate bed and other sites (i.e. lymph nodes or bones) will be evaluated. Location and avidity (standardized uptake value) of all identified PET positive sites will be recorded (series/slice number). Consensus read will be determined as positive or negative at the patient level as the consensus of at least 2 of the 3 reading radiologists. Detection rates will be presented with 95% confidence intervals.
Measured: Up to 2 years
Secondary outcomes (2)
Patient level verified detection rates
Patient level verified detection rates will be assessed directly by histopathology or indirectly by secondary imaging or serial imaging with treatment response over the course of 2 years from study scan. Results will be reported in tabular format.
Measured: Up to 2 years
Change in management plan based on POSLUMA scan
The change in management plan based on POSLUMA scan will be assessed as no, minor, or major change as dictated at provider's discretion after POSLUMA scan. Decisions regarding the care of the patient following PET/CT will be made and change from the pre-scan clinical pathway will be recorded subjectively by the treating physician as none, minor or major. Minor changes would include changes in intended frequency of monitoring, modifications within a radiation treatment field. Major changes would include changing from observation to treatment, treatment to observation, extension or inclusion of a new radiation treatment field, extension or reduction in duration of or use of additional systemic medications. Changes in management plans will be reported as frequencies and percentages.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start11 Apr 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemically Recurrent Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ashley Ross MD, PhD, Northwestern University
- Investigators
- Ashley E Ross, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813898
- Sponsor's protocol ID
- NU 24U08
- Other IDs
- NCI-2024-09380, STU00222061, NU 24U08, P30CA060553
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging
- ClinicalTrials.gov ID
- NCT06813898
- Acronym / sponsor ID
- NU 24U08
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 7 Feb 2025 (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.
This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography [PET]/computed tomography [CT]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.
Detailed description
PRIMARY OBJECTIVE:
- Determine consensus detection rate by flotufolastat F-18 gallium (rhPSMA-7.3)-PET (POSLUMA) scan in men with recent negative non-POSLUMA PET prostate specific membrane antigen (PSMA) scans.
SECONDARY OBJECTIVES:
- Determine patient level verified detection rates (by histopathology or a surrogate standard of truth [second contemporaneous imaging, treatment response/change in subsequent imaging]).
II. Determine change in management plan based on POSLUMA scan (major / minor).
EXPLORATORY OBJECTIVE:
- Determine patient and patient disease characteristics consistent with a positive POSLUMA scan at prostate specific antigen (PSA) < 0.5ng/ml (i.e. pathological Gleason grade, PSA at scan, time to biochemical recurrence [BCR], prostate-specific antigen doubling time [PSADT]).
OUTLINE:
Patients receive rhPSMA-7.3 intravenously (IV) and undergo PET/CT 60 minutes later on day 1.
After completion of study intervention, patients are followed up at 14 days and then every 3 months for 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (rhPSMA-7.3 PET/CT) | Experimental | Procedure: Computed Tomography, Other: Electronic Health Record Review, Drug: Flotufolastat F-18 Gallium, Procedure: Positron Emission TomographyPatients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy [i.e. salvage radiation])
- Men must have biochemical recurrence (defined as PSA >= 0.1ng/ml) after therapy
- PSA < 0.5ng/ml (within 90 days of enrollment)
- Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer
- Non-castrate testosterone (testosterone [T] > 50ng/dL) within 90 days of study entry
Key exclusion criteria (3 listed)
- Most recent PSA not between 0.1ng/ml and 0.5ng/ml
- Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T < 50ng/dl)
- Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)
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 |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET/CT | Procedure or surgery | Diagnostic (rhPSMA-7.3 PET/CT) |
| Electronic Health Record ReviewAncillary studies | Other | Diagnostic (rhPSMA-7.3 PET/CT) |
| Flotufolastat F-18 GalliumAlso: (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3Given IV | Drug | Diagnostic (rhPSMA-7.3 PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET/CT | Procedure or surgery | Diagnostic (rhPSMA-7.3 PET/CT) |
Primary outcome
Consensus detection rate
Time frame: Up to 2 years
Reads will be completed for the positron emission tomography (PET)/computed tomography (CT) by three trained radiologist blinded to each other's read. Uptake values of rhPSMA-7.3 (POSLUMA) in the prostate bed and other sites (i.e. lymph nodes or bones) will be evaluated. Location and avidity (standardized uptake value) of all identified PET positive sites will be recorded (series/slice number). Consensus read will be determined as positive or negative at the patient level as the consensus of at least 2 of the 3 reading radiologists. Detection rates will be presented with 95% confidence intervals.
2 secondary outcomes
Patient level verified detection rates
Time frame: Up to 2 years
Change in management plan based on POSLUMA scan
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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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.
Ashley E Ross principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Computed Tomography, Electronic Health Record Review and Flotufolastat F-18 Gallium in people with Biochemically Recurrent Prostate Carcinoma and Prostate Adenocarcinoma, run by Northwestern University 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 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: looking for participants now, as of the sponsor's last update on 2 Jul 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophia Kallas (312-694-9001, sophia.kallas@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consensus detection rate (time frame: Up to 2 years). 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 2 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.