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

JRCT ID: jRCTs032180303

Registered date:15/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 15/03/2019
• Target sample size: 240
• Study type: Interventional
• Intervention(s): Focal therapy for the localized prostate cancer with high-intensity focused ultrasound

Outcome(s)

• Primary Outcome: Oncological outcome, urinary incontinence, erectile dysfunction
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Shoji Sunao