RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2019-12-18
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03495427

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  3. * Previously enrolled to MCC#18523
  4. * Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
  5. * Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\>0.45)
  6. * Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
  7. * Age \> 18
  1. * No follow up information available post treatment
  2. * Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
  3. * 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

Contacts and Locations

Study Contact

Riley Smith
CONTACT
813-799-6821
Riley.Smith@moffitt.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-18
Study Completion Date2029-05

Study Record Updates

Study Start Date2019-12-18
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

  • radioactive diagnostic imaging

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Recurrent Prostate Cancer