The study was terminated early to integrate sites into a larger registry for a more comprehensive dataset, and not due to any safety concerns.

The objective of this study is to evaluate the clinical effectiveness and safety of treatment of prostate cancer in patients who have received a focal HIFU treatment using the Focal One medical device.

Inclusion Criteria:

• Patient eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.
• Patient newly diagnosed with localized prostate cancer confirmed with an image guided biopsy (MRI and/or micro-ultrasounds).
• Gleason ≤ 4+3.
• Patient scheduled for HIFU treatment as determined by the physician.
• Patient with healthcare coverage. Spanish-speaking patients with the ability to provide informed written consent

Exclusion Criteria:

• Patient with bilateral prostate cancer requiring whole gland treatment.
• Patients clinically detected metastasis.
• Patient with an extension of cancer or seminal vesicle invasion.
• Patient with contraindications for HIFU treatment: please refer to the complete Focal One user manual.

Patients newly diagnosed with localized prostate cancer and eligible for HIFU treatment for prostate cancer, excluding whole gland treatment.