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).
Histologically or cytologically confirmed biochemically recurrent prostate cancer, with original diagnosis no more than 2 years from date of consent.
Intermediate unfavorable or high-risk prostate cancer.
All patients under consideration for radiation therapy, either at the time of first recurrence or in salvage radiation therapy will be included.
Patients who have started bicalutamide up to a maximum of 3 days prior to randomization will be allowed to be on protocol. Otherwise, a washout period of at least 42 days will be required.
Patients currently on androgen deprivation therapy (ADTs).
Currently receiving any other investigational agents.
A history of allergic reactions attributed to compounds of similar chemical or biologic composition to POSLUMA, furosemide, bicalutamide, or other agents used in the study.
Parallel
Bicalutamide
DrugBicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care.
Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography
DevicePatients 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.
18F-rhPSMA-7.3
DrugRadioactive diagnostic agent for intravenous use.
PROSTest
Diagnostic testPROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments.
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).
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).
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.
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.
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.
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Washington University School of Medicine
Lead sponsor
The Society of Nuclear Medicine and Molecular Imaging
Collaborator
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