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
Brief Title
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).
Completion Date
Completion Date Type
Actual
Conditions
Prostate Cancer
Eligibility Criteria
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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
Male
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06604442
Org Class
Industry
Org Full Name
Blue Earth Diagnostics
Org Study Id
BED-PSMA-411
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
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).
Outcome Measure
To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET.
Outcome Time Frame
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
Secondary Outcomes
Outcome Description
Defined as the total number of patients with at least one PET positive lesion / total number of patients.
Outcome Time Frame
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
Outcome Measure
Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET
Outcome Description
Defined as the total number of patients with at least one PET positive lesion / total number of patients in PSA group.
Outcome Time Frame
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
Outcome Measure
Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET
Outcome Time Frame
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
Outcome Measure
Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET
Outcome Time Frame
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
Outcome Measure
Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ahmed Aboumohamed
Investigator Email
aaboumoh@montefiore.org
Investigator Department
Urology
Investigator Division
Oncology
Investigator Sponsor Organization
External
Study Department
Urology
Study Division
Please Specify
Categories Mesh Debug
Prostate Cancer --- PROSTATIC NEOPLASMS
Genitourinary (GU) & Urologic Cancers --- GENITAL NEOPLASMS, MALE
Genitourinary (GU) & Urologic Cancers --- UROGENITAL NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
MeSH Terms
PROSTATIC NEOPLASMS
GENITAL NEOPLASMS, MALE
UROGENITAL NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
GENITAL DISEASES, MALE
GENITAL DISEASES
UROGENITAL DISEASES
PROSTATIC DISEASES
MALE UROGENITAL DISEASES