Prostate Cancer (Post Prostatectomy)
Conditions
Keywords
Rising PSA following cancer prostatectomy surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUG18F-rhPSMA-7.3 (Posluma)
PET Scan using Posluma for detection of early recurrence of prostate cancer.
Sponsors
Blue Earth Diagnostics
AdventHealth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy. * An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5
Exclusion criteria
* Patients who are planned to have an x-ray contrast agent or other PET radiotracer & less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan. * Patients currently receiving Androgen Deprivation Therapy (ADT).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer Detection Rate | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation with biopsy | 24 months | In those patients who undergo biopsy of a lesion, correlation with pathology report diagnosis will be reviewed. |
| Correlation with other imaging modalities | 24 months | 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. |
| Response to therapy | 24 months | 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. |
| Adverse Events | 24 hours | 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 |
Countries
United States
Contacts
Primary ContactAdventHealth AdventHealth Oncology Research
Outcome results
None listed