Prostate Cancer
Conditions
Brief summary
Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men with Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
Detailed description
This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values \[SUV\]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).
Interventions
DRUGFlotufolastat (18F)
Positron emission tomography (PET)
Positron emission tomography (PET)
Sponsors
Aixial Group
Blue Earth Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Positron Emission Tomography (PET) Imaging study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male ≥18 years of age at Visit 1 (Screening). * Documented history of localized adenocarcinoma of the prostate with prior curative intent treatment with RP and undetectable PSA post-surgery, experiencing BCR of prostate cancer. * At least 6 months must have elapsed after RP. * Low PSA BCR defined as PSA ≤0.5 ng/mL. * Scheduled by their treating physician to receive a PSMA (18F) PET scan. * Written informed consent obtained from the patient and ability for the patient to comply with the requirements of the study.
Exclusion criteria
* Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements. * Patients who are planned to have an x-ray contrast agent or any other PET radiotracer within 24 hours prior to either PSMA PET scan. * Patients who have already received a piflufolastat (18F) PET scan prior to providing informed consent for this study. * Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to either of the PSMA PET scans in this study. * Patients with known hypersensitivity to the active substance or to any of the excipients of piflufolastat (18F) or flotufolastat (18F). * Patients who have previously undergone a cystectomy or have renal failure, or have other conditions that may significantly affect urinary output, as judged by the investigator. * Patients who have already received salvage therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET. | Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days | Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the following for piflufolastat (18F) PET and flotufolastat (18F) PET: Detection rates; Detection rates stratified by PSA level; Prostate bed detection rates: local recurrences by subregion; Pelvic lymph node (PLN) detection rates | Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days | Estimate of the following for each radiopharmaceutical: Patient-level detection rate; Patient-level detection rate by baseline PSA categories; Detection rate for local recurrences in prostate bed for the following subregions: vesicourethral anastomosis lesions; retrovesical lesions; remnant seminal vesicles/lateral surgical margin lesions; Detection rate for PLN lesions. |
Countries
United States
Outcome results
None listed