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

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495427
• Other study ID #: MCC-19291
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 18, 2019
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Riley Smith
• Phone: 813-799-6821
• Email: Riley.Smith[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Recurrent Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Positive PSMA-PET Findings	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.	Up to 5 years

External Links

•   Moffitt Cancer Center Clinical Trials website