NCT03495427

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
36mo left

Started Dec 2019

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Dec 2019May 2029

First Submitted

Initial submission to the registry

April 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 18, 2019

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

9.1 years

First QC Date

April 5, 2018

Last Update Submit

February 26, 2026

Conditions

Prostate CancerRecurrent Prostate Cancer

Keywords

radioactive diagnostic imaging

Outcome Measures

Primary Outcomes (1)

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

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

    Up to 5 years

Secondary Outcomes (1)

  • Rate of Positive PSMA-PET Findings

    Up to 5 years

Study Arms (1)

Radioactive Diagnostic Imaging

EXPERIMENTAL

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 InjectionDiagnostic Test: PSMA PET

Interventions

F-DCFPyL InjectionDRUG

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

Also known as: Imaging agent
Radioactive Diagnostic Imaging
PSMA PETDIAGNOSTIC_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.

Also known as: Prostate-specific Membrane Antigen (PSMA), Positron Emission Tomography (PET)
Radioactive Diagnostic Imaging

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-glycyl-asparagyl-glutaminyl-glutamyl-glutaminyl-valyl-seryl-prolyl-leucyl-threonyl-leucyl-leucyl-lysyl-lysyl-tryptophyl-cysteinyl-Alexa Fluoro 680 C2C2-maleimide conjugatePositron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Kosj Yamoah, M.D., Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Riley Smith

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 12, 2018

Study Start

December 18, 2019

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

US(1)