Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
MALE
ID03495427

The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipherae Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

P

Progenics Pharmaceuticals, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on men with prostate cancer who previously participated in a study called VANDAAM and had high-risk Decipher test results indicating a high genomic classifier (GC) score. The study aims to evaluate the safety and usefulness of a new imaging method called F-DCFPyL Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET) in detecting recurrent or metastatic prostate cancer. This imaging technique is not yet standard care but may improve how prostate cancer spread is identified and managed in the future. Participants will undergo F-DCFPyL PSMA PET imaging once a year for four years. Each imaging session involves receiving an injection of 9 b1 1 mCi of F-DCFPyL via a catheter placed in a vein. This radioactive diagnostic agent helps highlight cancer cells during the PET scan. The study includes men treated with surgery or radiation therapy at least two years prior and follows their imaging results over time. During the study, researchers will monitor the concordance between high tumor genomic risk scores and positive PSMA-PET imaging findings for up to five years. They will also track the rate of positive PSMA-PET results over this period. Participants' health is assessed with performance status evaluations, and the imaging is done annually. The total participation involves multiple annual imaging visits and follow-up evaluations to better understand the imaging test's value in detecting early metastatic prostate cancer.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Previously enrolled in MCC#18523 VANDAAM study with high-risk Decipher score (>0.45)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Genomic classifier testing completed on biopsy or surgical specimen
  • Treated with radical prostatectomy or radiation therapy, with or without short-term androgen deprivation therapy, and at least 2 years of follow-up
  • Male aged 18 years or older
Not Eligible

You will not qualify if you...

  • No follow-up information available after treatment
  • Unable to undergo PET imaging due to health conditions or claustrophobia
  • Received any radioisotope within 5 physical half-lives before study drug injection
  • Received any intravenous X-ray contrast medium within 24 hours before study drug injection
  • Received any high-density oral contrast medium within 5 days before study drug injection (oral water contrast is allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 years

Participants receive F-DCFPyL PSMA PET imaging to detect recurrent or metastatic prostate cancer.

Annual visits for PSMA PET imaging

Long-term Monitoring

Duration - Up to 3 years after initial imaging

Participants are monitored with yearly PSMA PET imaging after 2 years post-treatment to assess disease status.

Yearly visits for PSMA PET imaging

Trial Site Locations

Total: 1 location

1

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

R

Riley Smith

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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