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NCT Number: NCT03495427

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Kenneth Gage, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Kosj Yamoah, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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

Exclusion criteria

  • 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

Treatment and study plan

F-DCFPyL Injection

Drug

F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.

Other names: Imaging agent

PSMA PET

Diagnostic Test

PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.

Other names: Prostate-specific Membrane Antigen (PSMA), Positron Emission Tomography (PET)

Primary outcomes

  1. Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings

    Time frame: Up to 5 years

    To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.

Secondary outcomes

  1. Rate of Positive PSMA-PET Findings

    Time frame: Up to 5 years

    5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Riley Smith

CONTACT

[email protected]

813-799-6821

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Progenics Pharmaceuticals, Inc.

Registry information

Official study 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)

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Apr 12, 2018
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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