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

ConditionsProstate CancerRecurrent Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • F-DCFPyL Injection

    Drug

    F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.

  • PSMA PET

    Diagnostic test

    PSMA PET imaging (for men with high GC \>0.45) will be done after 2 years post-treatment, then yearly up to 5 years.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Radioactive Diagnostic ImagingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings

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

Time frame
Up to 5 years

Secondary outcomes

1

Rate of Positive PSMA-PET Findings

5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

Progenics Pharmaceuticals, Inc.

Collaborator

Source ClinicalTrials.gov
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