Investigational scan for detecting recurrent prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Northwestern University
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Ashley E Ross — Northwestern University
• Study coordinator: Sophia Kallas
• Email: sophia.kallas@northwestern.edu
• Phone: 312-694-9001

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Focal HDR-Brachytherapy for Prostate Cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.