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
Blue Earth Diagnostics
Aixial Group
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. | piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET 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). A positive difference represents a lower bladder SUVmean for flotufolastat (18F) compared to piflufolastat (18F). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET | piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days | Defined as the total number of patients with at least one PET positive lesion / total number of patients. |
| Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET | Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days | Defined as the total number of patients with at least one PET positive lesion / total number of patients in PSA group. |
| Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET | Screening, piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days | — |
| Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET | Piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian Helfand, M.D.
Endeavor Health NorthShore Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 40 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Baseline Body Mass Index (kg/m2) | 28.6 Kg/m2 STANDARD_DEVIATION 4.66 |
| Baseline Height | 177.3 cm STANDARD_DEVIATION 7.7 |
| Baseline Weight | 90.0 kg STANDARD_DEVIATION 16.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants |
| Race/Ethnicity, Customized Race Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race Unknown | 2 Participants |
| Race/Ethnicity, Customized Race White | 44 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 57 |
| other Total, other adverse events | 3 / 62 | 2 / 57 |
| serious Total, serious adverse events | 1 / 62 | 0 / 57 |
Outcome results
None listed