OncoMatch/Clinical Trials/NCT06402357
High Intensity Focused Ultrasound in Prostate Cancer
Is NCT06402357 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Focal One high intensity focused ultrasound device for prostate cancer.
Treatment: Focal One high intensity focused ultrasound device — This study will investigate the efficacy of focal high intensity focused ultrasound (HIFU) in patients with localized radiorecurrent prostate cancer. This study will also investigate the change in participant quality of life after HIFU therapy as compared to before HIFU therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA PET negative for metastatic disease
PSMA PET negative for metastatic disease (within 6 months of the biopsy)
Disease stage
Excluded: Stage ≥ CT3
Grade: GG2 or above (Grade Group)
Biopsy proven clinically significant prostate cancer (GG2 or above) recurrence within or ipsilateral to the ROI lesion; Evidence of ≥ cT3 recurrent disease on imaging [excluded]; Metastatic disease or locally advanced disease (defined by pelvic lymph node involvement or T4 disease) on PSMA PET [excluded]
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: radiation therapy — for prostate cancer
A history of prostate cancer treated with radiation therapy +/- hormone therapy
Cannot have received: hormonal therapy (relugolix, abiraterone, enzalutamide, apalutamide, darolutamide, casodex, firmagon, Lupron)
Exception: allowed if >6 months before screening
Hormone therapy within 6 months of the screening period (Hormone therapy includes oral (relugolix, abiraterone, enzalutamide, apalutamide, darolutamide, casodex) injections (firmagon, Lupron))
Cannot have received: radiation therapy
No prior radiation therapy for prostate cancer
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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