This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.
Patients will undergo prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography (PSMA PET-CT) imaging. Each PSMA PET-CT session will consist of 5 minutes of dynamic imaging conducted via the Biograph Vision Quadra PET-CT, a whole-body PET-CT scanner.
Radioactive diagnostic agent for intravenous use.
PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
Washington University School of Medicine
St Louis, Missouri, United States
Group B only: Lesion detection rates between PET1 and PET2.
Differences in lesion detection rates between Group B PET1 and PET2 will be analyzed by McNemar's test. Lesion detection rates will be reported by Group B patients at PET1 and PET2 scans and by the two scan sets (first 5 minutes and at 60 minutes post 18F-rhPSMA-7.3 injection).
Time frame: Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days)
Group A and B: Number of lesions detected on early scan versus delayed scan
The total number of lesions detected per patient will be summarized as counts. The number of lesions will be summarized by descriptive statistics for all patients at PET1, Group A patients at PET1, Group B patients at PET1, and Group B patients at PET2 and for each, by the two scan sets (early scan = first 5 minutes and at delayed scan = 60 minutes post 18F-rhPSMA-7.3 injection).
Time frame: At baseline and 14 days after start of bicalutamid treatment (total estimated time is 14 days)
Group A and B: Correlation between PSA response and PROSTest after radiation therapy
The correlation between PSA response and PROSTest after radiation therapy will be analyzed in Group A versus Group B. The results will be reported as a two-sample t-test or Wilcoxon sum rank test.
Time frame: Through day 90
Group A and B: Comparison of PSA response in patients who are treated with radiation vs. those treated with radiation
The comparison of PSA response will be analyzed in patients who are treated with radiation based on results of the PET2 versus those treated with radiation based on the results of PET1. The comparison will be reported as the results of a two-sample t-test or Wilcoxon sum rank test.
Time frame: Through day 90
Group B only: Correlation between PSA kinetics and detection rates between PET1 and PET2
The correlation between PSA kinetics and detection rates will be reported as the results of a two sample t-test or Wilcoxon sum rank test for each timepoint, PET1 and PET2.
Time frame: Through day 90
Group B only: Correlation between PROSTest results and detection rates of PET1 and PET2
Correlation between PROSTest results and detection rates of PET1 and PET2 will be reported as two sample t-test or Wilcoxon sum rank test. Results will be reported for PET1 and PET2.
Time frame: 14 days after start of bicalutamide treatment (total estimated time 14 days)
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