Investigational scan for detecting recurrent prostate cancer

ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging

This study is testing a new imaging technique to see if it can help find prostate cancer in men whose PSA levels are rising after treatment but who had a negative result on their last scan.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sex: Male
• Sponsor: Northwestern University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06813898 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of the rhPSMA-7.3 PET/CT imaging technique in detecting prostate cancer in men who have rising prostate-specific antigen (PSA) levels after previous treatment but tested negative for prostate-specific membrane antigen on their last PET scan. Participants will receive an intravenous injection of rhPSMA-7.3, followed by imaging to visualize areas where the tracer accumulates, indicating potential tumor presence. The study aims to determine the detection rate of this new imaging method and its impact on patient management. Follow-up assessments will occur at 14 days and every three months for two years to monitor outcomes.

Who should consider this trial

Good fit: Ideal candidates are men with a history of prostate adenocarcinoma who have experienced biochemical recurrence and have had negative or equivocal PET PSMA imaging.

Not a fit: Patients who have not undergone prior treatment for prostate cancer or those with PSA levels above 0.5ng/ml may not benefit from this study.

Why it matters

Potential benefit: If successful, this imaging technique could improve the detection of recurrent prostate cancer, leading to better management and treatment options for patients.

How similar studies have performed: Other studies have shown promise with similar imaging techniques, but this specific approach using rhPSMA-7.3 is relatively novel.

Eligibility criteria

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)

Where this trial is running

Chicago, Illinois

• Northwestern University — Chicago, Illinois, United States (RECRUITING)

Study contacts

• Principal investigator: Ashley E Ross — Northwestern University
• Study coordinator: Sophia Kallas

Conditions: Biochemically Recurrent Prostate Carcinoma, Prostate Adenocarcinoma