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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032180303
Enrollment
240
Registered
2019-03-15
Start date
2016-06-14
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate cancer

Interventions

Sponsors

Shoji Sunao
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Oncological outcome, urinary incontinence, erectile dysfunction

Secondary

MeasureTime frame
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)

Contacts

Public ContactSunao Shoji

Tokai University

sunashoj@mail.goo.ne.jp+81-463-93-1121

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026