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Recruiting NCT03495427

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

Phase II / Phase III Interventional Prostate Cancer Recurrent Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: F-DCFPyL Injection, PSMA PET.
Who it may be relevant to
Registry conditions: Prostate Cancer, Recurrent Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

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.

Detailed description

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.

Interventions

  • Drug F-DCFPyL Injection
    F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
  • Diagnostic test PSMA PET
    PSMA PET imaging (for men with high GC \>0.45) will be done after 2 years post-treatment, then yearly up to 5 years.

Primary outcome measures

  • Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings [Time frame: Up to 5 years]
Secondary outcome measures (1)
  • Rate of Positive PSMA-PET Findings [Time frame: Up to 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • H. Lee Moffitt Cancer Center and Research Institute — Tampa

Identifiers

NCT: NCT03495427 · MCC-19291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗