Flotufolastat F18 PET/CT to find residual or recurrent prostate cancer after focal therapy

Eclipse: Flotufolastat F 18 to Determine Treatment Success Following Prostate Focal Therapy

This test will see if flotufolastat F18 PET/CT can find prostate cancer that remains or comes back in men after focal therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years to 90 Years
• Sex: Male
• Sponsor: Jonsson Comprehensive Cancer Center (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT07185165 on ClinicalTrials.gov

What this trial studies

Participants receive an IV injection of flotufolastat F18 and undergo whole-body PET/CT about 50–100 minutes later, with imaging lasting roughly 20–50 minutes. Within three months of imaging, participants undergo PET/CT–ultrasound fusion guided prostate biopsy to confirm presence or absence of cancer. The primary aim is to compare the accuracy of flotufolastat F18 PET/CT against prostate biopsy for determining treatment success after focal therapy, and the secondary aim is to relate PET standardized uptake values (SUV) to Gleason score. An exploratory objective compares intraprostatic distribution of flotufolastat F18 with Ga‑68 PSMA‑11 in men previously treated with focal therapies, and participants are followed for outcomes for up to 10 years.

Who should consider this trial

Good fit: Men aged 18–90 with a history of prostate cancer who had focal therapy (for example HIFU, cryotherapy, laser, IRE, or brachytherapy) 6–36 months earlier and who are eligible for prostate biopsy.

Not a fit: Patients with contraindications to PET/CT or ultrasound‑guided prostate biopsy, those with castrate testosterone from recent androgen‑deprivation therapy, or those unable to lie still for imaging are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this imaging approach could help doctors locate residual or recurrent tumors earlier and guide targeted biopsies or retreatment.

How similar studies have performed: PSMA‑targeted PET imaging (including Ga‑68 PSMA‑11 and other F‑18 tracers) has demonstrated success for detecting recurrent prostate cancer, but using flotufolastat F18 specifically after focal therapy is less well studied and is being explored in this trial.

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)

Where this trial is running

Los Angeles, California

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)

Study contacts

• Principal investigator: Wayne Brisbane — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Kyla Grunden

Conditions Prostate Carcinoma