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

Last updated: September 18, 2025
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Overall Status: Active - Recruiting

Phase

2/3

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

PSMA PET

F-DCFPyL Injection

Clinical Study ID

NCT03495427
MCC-19291
  • Ages > 18
  • Male

Study Summary

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

Inclusion

Inclusion Criteria:

  • This study will enroll 60 patients previously enrolled to MCC#18523, "A ValidationStudy on the Impact of Decipher® Testing on Treatment Recommendations inAfrican-American and Non-African American Men with Prostate Cancer: (VANDAAM)" thathad 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 surgicalspecimen

  • Decipher score from participation on the MCC#18523 study meets the criteria forhigh-risk (>0.45)

  • Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-termandrogen deprivation therapy (ADT)) with ≥2 years follow up

  • Age > 18

Exclusion

Exclusion Criteria:

  • No follow up information available post treatment

  • Unable to undergo PET imaging due to pre-existing comorbidities and/orclaustrophobia

  • Administration of any radioisotope within 5 physical half-lives OR any IV X-raycontrast medium within 24 hours OR any high-density oral contrast medium (oral watercontrast acceptable) within 5 days prior to study drug injection

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: PSMA PET
Phase: 2/3
Study Start date:
December 18, 2019
Estimated Completion Date:
May 31, 2029

Study Description

Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.

Connect with a study center

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

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