Focal therapy with high-intensity focused ultrasound for the localized prostate cancer

Phase 3

• Conditions: prostate cancer; C566426

• Registration Number: JPRN-jRCTs032180303
• Lead Sponsor: Shoji Sunao

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

1. Patients who have localized prostate cancer with above 20 years old.
2. Patients who were diagnosed the localization of the significant cancer in the prostate.
3. Patients who were informed of this procedure , and underwent this procedure provided informed consent.

Exclusion Criteria

1. Patients who have severe anal strictures.
2. Patients who have prostatic calcification over 10mm in the front of the target lesion.
3. Patients who have the target lesion located out of the treatable area.
4. Patients who were regarded as a inappropriate for the treatment by the responsible doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oncological outcome, urinary incontinence, erectile dysfunction

Secondary Outcome Measures

Name	Time	Method
Evaluation of the blood flow in treated area on dynamic contrast enhanced MRI, Follow-up biopsy in 6 months after the treatment, Serum PSA value in 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the treatment, Urinary function (IPSS, IPSS QOL, OABSS, Uroflowmetry, Residual urine), Sexual function (IIEF-5, FACT-P), Quality of life (SF-36, FACT-G), Complications (Common Terminology Criteria for Adverse Events version 4.0)