ES-HIFU, Prospective Data Collection of Patients Treated With Partial Gland HIFU Ablation for Prostate Cancer

EDAP TMS

Status: Terminated

Conditions: Prostate Cancer

Treatments: Device: FocalOne

Study type: Observational

Funder types: Industry

Identifiers

NCT06375629

EDAP TMS

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.