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Trial 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
NCT ID:
NCT06604442
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Recurrence
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Positron Emission Tomography (PET) Imaging study
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Flotufolastat (18F)
Description:
Positron emission tomography (PET)
Arm group label:
piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)
Intervention type:
Drug
Intervention name:
piflufolastat (18F)
Description:
Positron emission tomography (PET)
Arm group label:
piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)
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).
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
May 2025
Lead sponsor:
Agency:
Blue Earth Diagnostics
Agency class:
Industry
Collaborator:
Agency:
Aixial Group
Agency class:
Industry
Source:
Blue Earth Diagnostics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06604442
