PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
Status
RECRUITING
Phase
PHASE2
Age
≥ 18 Years
Enrollments
30Conditions
Prostate Cancer (Post Prostatectomy)Drugs
18F-rhPSMA-7.3 (Posluma)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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- AdventHealth AdventHealth Oncology Research
- 407-303-2090
- [email protected]
Eligibility Criteria
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).
Study Plan
Open Label Main Arm
OTHER
Single Arm receiving PET scan with 18F-rhPSMA-7.3 (Posluma)
DRUG:
18F-rhPSMA-7.3 (Posluma)Description:
PET Scan using Posluma for detection of early recurrence of prostate cancer.
Outcome Measures
Primary Outcome Measures
Cancer Detection Rate
Secondary Outcome Measures
Correlation with biopsy
Correlation with other imaging modalities
Response to therapy
Adverse Events
Timeline
Last Updated
October 24, 2024Start Date
September 27, 2024Today
January 16, 2025Completion Date ( Estimated )
October 10, 2027
Sponsors of this trial
Lead Sponsor
AdventHealthCollaborating Sponsors
Blue Earth Diagnostics
RECRUITING 
21 - 64 Years