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| Name | Class |
|---|---|
| The Society of Nuclear Medicine and Molecular Imaging | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Baseline PSMA PET/CT only with standard of care bicalutamide | Active Comparator | Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma). After the 18F-rhPSMA-7.3 injection, patients will undergo research imaging consisting of 5 minutes of PET imaging, followed by routine imaging at 60 minutes after 18F-rhPSMA-7.3 injection. Patients will have blood collected for PROSTest and PSA within 1 day of completion of PET1. Following PET1, patients will initiate standard of care bicalutamide for a minimum of 14 days, with the first dose taken the day after PET1. Patients will undergo a 90 day follow-up visit (relative to PET1) for collection of blood for PROSTest and PSA. |
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| Group B: PSMA PET/CT after 2 weeks of standard of care bicalutamide | Experimental | Patients will undergo baseline PSMA PET/CT (PET1) with 18F-rhPSMA-7.3 (F-18 flotufolastat, Posluma). After the 18F-rhPSMA-7.3 injection, patients will undergo research imaging consisting of 5 minutes of PET imaging, followed by routine imaging at 60 minutes after 18F-rhPSMA-7.3 injection. Patients will have blood collected for PROSTest and PSA within 1 day of completion of PET1. Following PET1, patients will initiate standard of care bicalutamide for a minimum of 14 days, with the first dose taken the day after PET1 and will undergo a research PSMA PET/CT (PET2) on Day 14 (±3 days). The research PSMA PET/CT (PET2) will follow the same imaging procedures as the baseline PET. Patients will undergo a 90 day follow-up visit (relative to PET1) for collection of blood for PROSTest and PSA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide is a non-steroidal androgen receptor inhibitor administered as a once a day pill taken orally. This is given as standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 14 days after start of bicalutamide treatment (total estimated time 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vikas Prasad, MD, PhD | Contact | 314-632-2812 | pvikas@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vikas Prasad, MD, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Prostate-specific membrane antigen Positron Emission Tomography-Computed Tomography | Device | 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. |
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| 18F-rhPSMA-7.3 | Drug | Radioactive diagnostic agent for intravenous use. |
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| PROSTest | Diagnostic Test | PROSTest is a novel, blood-based qPCR assay that assesses gene expression to diagnose PCa and predict patient outcomes to different treatments. |
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| 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. | 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. | 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. | 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. | 14 days after start of bicalutamide treatment (total estimated time 14 days) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C053541 | bicalutamide |
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