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

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · Apr 5, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness of a special imaging test called PSMA-PET in detecting early signs of metastatic prostate cancer in men who have previously been identified as high-risk due to their Decipher test scores. The study will include 60 men who participated in an earlier study and had a Decipher score over 0.45, indicating a higher chance of their cancer spreading. Eligible participants are men over 18 years old who have had treatment for prostate cancer, such as surgery or radiation, and have been followed for at least two years.

If you or a loved one qualifies for this trial, you can expect to undergo PSMA-PET imaging, which helps doctors see if the cancer has spread to other parts of the body. It is important to know that participants must not have any conditions that would prevent them from having this imaging test, and they should not have received certain treatments right before the study. This trial hopes to improve how we detect and treat early metastatic prostate cancer, ultimately helping men with this condition.

Gender

MALE

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