Localized prostate cancer Prostate cancer
Conditions
Sponsors
Shoji Sunao
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients with serum PSA level of 20 ng/mL or less at the time of consent 2. Patients over 20 years old at the time of consent 3. Patients who meet a and b below a Localized cancer with cT1c to cT2cN0M0 and Gleason score 4+4=8 or less. *In case of Gleason score 4+4, patients required to be over 70 years old at the time of consent or patients in difficulty to receive surgery due to physical function or patients in difficulty to receive prostate radiation therapy due to post-radiation therapy for other diseases in pelvic area. b Exclude patients in which the peripheral zone on both side and entire urethra are included in the treatment area because it is expected to affect sexual function and urinary function and the usefulness of Focal therapy may not be obtained. 4. Patients who were diagnosed the localization of the significant cancer in the prostate. 5. Patients who have received sufficient explanation in participating in this research and obtained written consent at his own will. 6. Patients who have not received endocrine therapy, or more than half a year has passed by the time consent is obtained after the endocrine therapy is completed (interrupted) 7. Patients with no indication of rectal involvement of prostate cancer.
Exclusion criteria
Exclusion criteria: 1. Patients who have severe anal strictures. 2. Patients who have prostatic calcification over 10mm in front of the target lesion. 3. Patients who have the target lesion located out of the treatment area. 4. Patients who were evaluated as an inappropriate for the general or spinal anesthesia. 5. Patients diagnosed with castration-resistant prostate cancer. 6. Patients who have already had urinary incontinence and are using urine pads on a daily basis. 7. Patients with a history of diabetes and poor control (HbA1c 8.0 or higher in blood test within 3 months before obtaining consent) 8. Patients who are taking anticoagulants or antiplatelet drugs without washout periods for each drug 9. Patients with blood coagulation disorder who were evaluated as having difficulty in surgery within 3 months before obtaining consent (platelets2.0) 10.Patients with easily infectious status within 3 months before obtaining consent.(WBC12*10^3/uL, Creatinine (Cr) >2.0 mg/dL, AST>100 IU/L, ALT>100 IU/L or Hemoglobin<8.0g/dL 12. Patients who are regarded as an inappropriate for the treatment by the responsible doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-years recurrence-free survival, Occurrence of urinary incontinence | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 5-years overall survival 2. 5-years recurrence free survival with significant cancer detection from treated- and un-treated area. 3. 5-years recurrence free survival with significant cancer detection from treated area. 4. Rate of the patients who were received 2 treatments of focal therapy with HIFU of all patients. 5. Rate of the complications in the patients who were received 2 treatments of focal therapy with HIFU. 6. Rate of the patients with disappearance of blood flow in the treated area on dynamic contrast-enhanced MRI in all patients. 7. Contents of salvage treatments for the recurrences after focal therapy with HIFU. | — |
Contacts
Public ContactSunao Shoji
Tokai University Hospital
Outcome results
None listed