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

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03495427
Collaborator
Progenics Pharmaceuticals, Inc. (Industry)
60
Enrollment
1
Location
1
Arm
41.4
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: F-DCFPyL Injection
  • Diagnostic Test: PSMA PET
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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)
Actual Study Start Date :
Dec 18, 2019
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Radioactive Diagnostic Imaging

Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access.

Drug: F-DCFPyL Injection
F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
Other Names:
  • Imaging agent
  • 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.
    Other Names:
  • Prostate-specific Membrane Antigen (PSMA)
  • Positron Emission Tomography (PET)
  • Outcome Measures

    Primary Outcome Measures

    1. Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings [Up to 5 years]

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

    Secondary Outcome Measures

    1. Rate of Positive PSMA-PET Findings [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1H. Lee Moffitt Cancer Center and Research InstituteTampaFloridaUnited States33612

    Sponsors and Collaborators

    • H. Lee Moffitt Cancer Center and Research Institute
    • Progenics Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Kosj Yamoah, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT03495427
    Other Study ID Numbers:
    • MCC-19291
    First Posted:
    Apr 12, 2018
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 8, 2021