Prostate CancerPhase 2NCT07733908
Effectiveness of Posluma PET Scan for Post-Treatment Monitoring of Prostate Cancer
A Phase 2 study testing Posluma PET in people with Prostate Cancer, run by Aditya Bagrodia.
Trial summary
To determine the effectiveness of Posluma PET Scan for monitoring prostate cancer patients after targeted treatment, including how accurately it can detect any remaining or returning cancer after about 12 months post-treatment. 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?
- Posluma PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jul 2030
- Phase
- Phase 2
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: Histologically confirmed PCa.
- Risk Profile: Intermediate-risk , organ-confined PCa
- Eligibility for Focal Therapy: Determined to be an appropriate candidate for focal therapy based on clinical evaluation.
- Age: 18 years or older.
- Life Expectancy: Expected survival of at least 10 years.
- Informed Consent: Ability to understand and willingness to sign the informed consent form.
Who cannot join
- Previous Treatment: Prior treatment for PCa, including radiation therapy, chemotherapy, focal therapy, or androgen deprivation therapy.
- Severe Comorbid Conditions: Presence of severe comorbid conditions that may interfere with study participation, such as uncontrolled cardiovascular, renal, hepatic, or metabolic diseases.
- Contraindications to Imaging: Known hypersensitivity to components of the Posluma PSMA radiotracer, or inability to undergo PET or MRI imaging due to medical or anatomical constraints (e.g., severe claustrophobia, metallic implants incompatible with MRI).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Posluma PET Scan in Evaulation and Monitoring of Patients Undergoing Focal Therapy for Prostate Cancer
To determine the effectiveness of Posluma PET Scan for monitoring prostate cancer patients after targeted treatment, including how accurately it can detect any remaining or returning cancer after about 12 months post-treatment.
Read the detailed description
This Phase II study will employ Posluma PSMA PET scans both preoperatively, for evaluation of lesions prior to focal therapy, and postoperatively, for monitoring recurrence and verifying treatment success. Imaging findings from Posluma PET will be compared with standard MRI and biopsy results to validate Posluma PET as an advanced diagnostic tool for improving PCa detection in patients undergoing focal therapy as well as postoperative follow-up after the procedure.
- Conditions
- Prostate Cancer
- Being tested
- Posluma PET
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posluma PETDiagnostic test
Posluma® (flotufolastat F 18) is an FDA-approved diagnostic PET imaging agent used to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It helps pinpoint the location of cancer when metastasis is suspected or when recurrence occurs due to elevated PSA levels.
| Study group | Role | What they receive |
|---|---|---|
| Posluma PET | Experimental | Participants will undergo Posluma PSMA PET scans at two time points: preoperatively to evaluate the extent of disease prior to focal therapy and postoperatively for monitoring treatment success and detecting potential recurrence. The Posluma PET imaging will be conducted on a PET/CT scanner with optimized protocols for PCa lesion detection. PET scan data will be analyzed in comparison with MRI and biopsy results. All imaging will be performed at UCSD, ensuring consistent imaging quality and scanner calibration across all patients. Receives: Diagnostic Test: Posluma PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy
To determine the sensitivity and specificity of the Posluma PSMA PET scan in detecting residual or recurrent prostate cancer lesions approximately 12 months after focal therapy, compared to MRI and biopsy data.
Measured: 12 months
Accuracy of Posluma PSMA PET Imaging for Detection of Residual and Recurrent Disease for Prostate Cancer
To evaluate whether Posluma PSMA PET imaging can accurately detect residual or recurrent disease measured by comparison with MRI and biopsy results
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aditya Bagrodia
- Sponsor type
- University, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Responsible party
- Sponsor-investigator, Aditya Bagrodia, University of California, San Diego
- Investigators
- Aditya Bagrodia, MD, FACS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733908
- Sponsor's protocol ID
- 812089
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Posluma PET Scan in Evaulation and Monitoring of Patients Undergoing Focal Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT07733908
- Acronym / sponsor ID
- 812089
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Aditya BagrodiaUniversity, hospital or other
- Collaborators
- Blue Earth Diagnostics
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 29 Jul 2026 (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.
To determine the effectiveness of Posluma PET Scan for monitoring prostate cancer patients after targeted treatment, including how accurately it can detect any remaining or returning cancer after about 12 months post-treatment.
Detailed description
This Phase II study will employ Posluma PSMA PET scans both preoperatively, for evaluation of lesions prior to focal therapy, and postoperatively, for monitoring recurrence and verifying treatment success. Imaging findings from Posluma PET will be compared with standard MRI and biopsy results to validate Posluma PET as an advanced diagnostic tool for improving PCa detection in patients undergoing focal therapy as well as postoperative follow-up after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Posluma PET | Experimental | Diagnostic Test: Posluma PETParticipants will undergo Posluma PSMA PET scans at two time points: preoperatively to evaluate the extent of disease prior to focal therapy and postoperatively for monitoring treatment success and detecting potential recurrence. The Posluma PET imaging will be conducted on a PET/CT scanner with optimized protocols for PCa lesion detection. PET scan data will be analyzed in comparison with MRI and biopsy results. All imaging will be performed at UCSD, ensuring consistent imaging quality and scanner calibration across all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis: Histologically confirmed PCa.
- Risk Profile: Intermediate-risk , organ-confined PCa
- Eligibility for Focal Therapy: Determined to be an appropriate candidate for focal therapy based on clinical evaluation.
- Age: 18 years or older.
- Life Expectancy: Expected survival of at least 10 years.
Key exclusion criteria (3 listed)
- Previous Treatment: Prior treatment for PCa, including radiation therapy, chemotherapy, focal therapy, or androgen deprivation therapy.
- Severe Comorbid Conditions: Presence of severe comorbid conditions that may interfere with study participation, such as uncontrolled cardiovascular, renal, hepatic, or metabolic diseases.
- Contraindications to Imaging: Known hypersensitivity to components of the Posluma PSMA radiotracer, or inability to undergo PET or MRI imaging due to medical or anatomical constraints (e.g., severe claustrophobia, metallic implants incompatible with 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 |
|---|---|---|
| Posluma PETPosluma® (flotufolastat F 18) is an FDA-approved diagnostic PET imaging agent used to detect prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. It helps pinpoint the location of cancer when metastasis is suspected or when recurrence occurs due to elevated PSA levels. | Diagnostic test | Posluma PET |
Primary outcome
Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy
Time frame: 12 months
To determine the sensitivity and specificity of the Posluma PSMA PET scan in detecting residual or recurrent prostate cancer lesions approximately 12 months after focal therapy, compared to MRI and biopsy data.
Accuracy of Posluma PSMA PET Imaging for Detection of Residual and Recurrent Disease for Prostate Cancer
Time frame: 12 months
To evaluate whether Posluma PSMA PET imaging can accurately detect residual or recurrent disease measured by comparison with MRI and biopsy results
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 14 Aug 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.
Aditya Bagrodia, MD, FACS principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posluma PET in people with Prostate Cancer, run by Aditya Bagrodia.
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 6 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Translational Research Team ((858) 822-5354, CancerCTO@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy (time frame: 12 months). 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?
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 14 Aug 2026.