Recruiting
Early Phase 1

rhPSMA-7.3

Sponsor:

Northwestern University

Code:

NCT06813898

Conditions

Biochemically Recurrent Prostate Carcinoma

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Electronic Health Record Review

Flotufolastat F-18 Gallium

Positron Emission Tomography

Study Details

Brief 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 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.

Conditions

Biochemically Recurrent Prostate Carcinoma

Prostate Adenocarcinoma

Study ID

NCT06813898

Start date

Apr 11, 2025

Status verified date

Jun, 2026

Completion date

Feb 1, 2032

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (rhPSMA-7.3 PET/CT)

Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

Interventions

Computed Tomography

Undergo PET/CT

Electronic Health Record Review

Ancillary studies

Flotufolastat F-18 Gallium

Given IV

Positron Emission Tomography

Undergo PET/CT

Primary outcome measure

  • Consensus detection rate [ Time Frame: Up to 2 years ]

Central Contacts and Locations

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Ashley E. Ross

More Information

Sponsor

Northwestern University

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-07-02.