Overview
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.
Eligibility
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.