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PSMA-PET Imaging for Early Metastatic Prostate Cancer in Men with High Decipher Scores

This study is looking at a new imaging test called F-DCFPyL-PSMA PET to see how well it finds prostate cancer that has come back or spread (recurrent/metastatic prostate cancer). The F-DCFPyL Injection is a special radioactive dye used with the PSMA PET scan. Researchers want to see if this new scan can accurately detect early signs of cancer spread in men who had high-risk Decipher test scores when they were first diagnosed. The study will enroll 60 men who previously participated in another study (VANDAAM) and had high Decipher scores (above 0.45). The main goal is to see how well the high Decipher score matches up with positive findings on the PSMA-PET imaging over a period of up to 5 years.

Study design
This is an interventional study planning to enroll 60 male participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo PSMA PET imaging at 2 years after your initial treatment, and then yearly for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure the concordance between their Decipher score and PSMA-PET findings.

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NCT03495427

PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
H. Lee Moffitt Cancer Center and Research Institute
~60 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:F-DCFPyL InjectionPSMA PET

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Measured over Up to 5 years

Conditions

Prostate Cancer
Recurrent Prostate Cancer

Explore related trials

Prostate CarcinomaDecipher

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Kosj Yamoah, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · H. Lee Moffitt Cancer Center and Research Institute

Who to contact

Riley Smith
[email protected]
813-799-6821
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45).
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
Previously enrolled to MCC#18523
Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\>0.45)
Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
Age \> 18

Exclusion

No follow up information available post treatment
Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection

What this trial measures

  • Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging FindingsUp to 5 years

    To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.