RecruitingPhase 2Phase 3NCT03495427

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

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)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

60 participants

Start Date

Dec 18, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is using a specialized type of imaging scan (called PSMA-PET) to detect whether prostate cancer has spread to other parts of the body in men who had surgery or radiation and whose tumors were identified as high risk through a genetic test called Decipher. **You may be eligible if...** - You previously took part in the VANDAAM study (MCC#18523) - Your Decipher genetic test score was high risk (above 0.45) - You were treated with surgery (prostate removal) or radiation therapy, with at least 2 years of follow-up since then - You are 18 years of age or older - Your general health is good (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You did not participate in the prior VANDAAM study - Your Decipher score did not meet the high-risk threshold - Your genetic test results from that study were not successfully completed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGF-DCFPyL Injection

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

DIAGNOSTIC_TESTPSMA 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(1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

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NCT03495427


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