NCT07185165 An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.
| NCT ID | NCT07185165 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jonsson Comprehensive Cancer Center |
| Condition | Prostate Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2025-10-09 |
| Primary Completion | 2035-10-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 81 participants in total. It began in 2025-10-09 with a primary completion date of 2035-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to other methods.
Eligibility Criteria
Inclusion Criteria: * Men aged 18-90 at study enrollment * History of prostate cancer * Men who have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound \[HIFU\], Tulsa Pro, irreversible electroporation \[IRE\], brachytherapy) within 6-36 months of enrollment Exclusion Criteria: * Contraindication to flotufolastat F 18 PET CT * Contraindication to ultrasound-guided prostate biopsy * Patients who are planned to have an x-ray contrast agent or other PET radiotracer \< 24 hours prior to the PET scan * Patients with castrate levels of testosterone secondary to androgen deprivation therapy * Inability to provide written informed consent * Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes) * Any investigational agents within 42 days prior to the day of the first dose * Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)
Contact & Investigator
Wayne Brisbane
PRINCIPAL INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT07185165 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 90 Years, studying Prostate Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07185165 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07185165 currently recruiting?
Yes, NCT07185165 is actively recruiting participants. Contact the research team at kgrunden@mednet.ucla.edu for enrollment information.
Where is the NCT07185165 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07185165 clinical trial?
NCT07185165 is sponsored by Jonsson Comprehensive Cancer Center. The principal investigator is Wayne Brisbane at UCLA / Jonsson Comprehensive Cancer Center. The trial plans to enroll 81 participants.