Clinical trial NCT06604442: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Prostate Cancer
Lead sponsor: Blue Earth Diagnostics
Sponsor class: INDUSTRY
Collaborators: name: Aixial Group
First posted: 2024-09-19
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Positron Emission Tomography (PET) Imaging study
Primary purpose: DIAGNOSTIC

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).

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.

Primary outcomes:
measure: To compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
timeFrame: Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
Secondary outcomes:
measure: 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
timeFrame: Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Glenview
country: United States
facility: Endeavor Health- Glenbrook Hospital
state: Illinois
city: Omaha
country: United States
facility: XCancer Omaha/Urology Cancer Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: San Antonio
country: United States
facility: Urology San Antonio
state: Texas
Study officials:
affiliation: Endeavor Health NorthShore Hospital
name: Brian Helfand, M.D.
role: PRINCIPAL_INVESTIGATOR
References: