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| ID | Type | Description | Link |
|---|---|---|---|
| IRBNet # 2067493 | Other Identifier | AdventHealth |
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| Name | Class |
|---|---|
| Blue Earth Diagnostics | INDUSTRY |
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Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer.
The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
This is not an investigational study drug. Flotufolastat PET scan is FDA Approved for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. In this research study, the flotufolastat-PET scan will be repeated if the initial scan does not show cancer and if PSA further rises by greater than 0.1 ng/ml. Other currently used scans for this purpose do not detect cancer in all patients with low levels of rising PSA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Main Arm | Other | Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-rhPSMA-7.3 (Posluma) | Drug | PET Scan using Posluma for detection of early recurrence of prostate cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cancer Detection Rate | Patients who undergo at least one rhPSMA-7.3 (18F) PET-scan will be analyzed for the primary endpoint. The malignant lesion detectability rate will be summarized using percentage and 95% confidence interval estimates overall and for those who underwent a single scan or both scans. The diagnostic evaluation aims to identify individuals who are most likely to have an isolated local relapse, as they have the most significant potential for achieving long-term disease control through additional local therapy. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with biopsy | In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed. | 24 months |
| Correlation with other imaging modalities | In those patients who undergo other imaging modalities to confirm the results of the rhPSMA-7.3 (18F) PET-scan, correlation with other imaging modalities will be reviewed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AdventHealth AdventHealth Oncology Research | Contact | 407-303-2090 | CFD.ResearchOncology@AdventHealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth | Recruiting | Orlando | Florida | 32804 | United States |
Decision to be made at the end of enrollment period of 30 patients
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 24 months |
| Response to therapy | In those patients who undergo cancer directed therapy with radiation alone or with androgen deprivation therapy, the follow-up PSA test values after therapy will be reported. | 24 months |
| Adverse Events | Safety and toxicity data will be collected to evaluate any patient reported adverse effects. Safety Follow-up Call Within 24 hours of each Injection/Scan | 24 hours |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |