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Trial Title:
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
NCT ID:
NCT06617481
Condition:
Prostate Cancer (Post Prostatectomy)
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Conditions: Keywords:
Rising PSA following cancer prostatectomy surgery
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-rhPSMA-7.3 (Posluma)
Description:
PET Scan using Posluma for detection of early recurrence of prostate cancer.
Arm group label:
Open Label Main Arm
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.
Criteria for 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).
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
AdventHealth
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Recruiting
Contact:
Last name:
AdventHealth AdventHealth Oncology Research
Phone:
407-303-2090
Email:
CFD.ResearchOncology@AdventHealth.com
Contact backup:
Last name:
Guru Sonpavde, MD, MD
Start date:
September 20, 2024
Completion date:
October 10, 2027
Lead sponsor:
Agency:
AdventHealth
Agency class:
Other
Collaborator:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Source:
AdventHealth
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06617481
