Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
MALE
NCT03495427

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

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

60

Participants Needed

1

Research Sites

488 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 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.

CONDITIONS

Official 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
  • High-risk Decipher test score above 0.45
  • ECOG performance status of 0 or 1
  • Completed genomic classifier testing on biopsy or surgical specimen
  • Treated with radical prostatectomy or radiation therapy with or without short-term androgen deprivation therapy
  • At least 2 years of follow-up post-treatment
  • 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 other 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 (except oral water) within 5 days before study drug injection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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