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

Description

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

Prostate Cancer, Recurrent Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Tampa

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States, 33612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

H. Lee Moffitt Cancer Center and Research Institute,

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

Study Record Dates

2029-05