Salvage Treatment with High-Intensity Focused Ultrasound for the Patients with Localized Recurrent Prostate Cancer Following Radiation Therapy.

JRCT ID: jRCTs032240299

Registered date:26/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prostate cancer
• Date of first enrollment: 26/08/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): High-intensity focused ultrasound for the localized recurrent prostate cancer following radiation therapy

Outcome(s)

• Primary Outcome: 2-year cancer-specific recurrence-free survival

Secondary Outcome

1. 2-year overall survival rate
2. 2-year recurrence-free survival rate from within the treatment area
3. Percentage of patients with loss of blood flow in the treatment area based on dynamic MRI blood flow analysis of cancer localization taken at 4 weeks after treatment among all enrolled patients
4. Treatment options after recurrence

Key inclusion & exclusion criteria

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

Include criteria

1. Patients with a serum PSA level of 20 ng/mL or less at the time of obtaining consent.
2. Patients who are 20 years of age or older at the time of obtaining consent.
3. Patients with localized recurrent prostate cancer following radiation therapy.
Patients must fulfill the following criteria:
a. Patients who have undergone MRI imaging techniques and who have undergone radiotherapy. Patients with cT1c-cT2cN0M0 localized prostate cancer with a Gleason score of 4+4=8 or less (Gleason score 3+3, 3+4, 4+3, 4+4), who have been diagnosed by MRI imaging techniques, transperineal targeted prostate biopsy, and transperineal systematic 12-point biopsy. 3, 4+4, 4+3, 4+4).
b. Patients whose treatment area includes both peripheral zones and the entire urethra will be excluded from the study because of the possibility of increased complication frequency and the possibility of not benefiting from localized salvage cancer therapy. Patients who have been fully informed about their participation in this clinical research and have given written consent of their own free will.
4. No hormonal therapy or at least six months must have elapsed since completion (interruption) of hormonal therapy by the time consent is obtained.
5. No rectal invasion of the prostate cancer.

Exclude criteria

1. Patients who have difficulty inserting the transrectal ultrasound probe due to anal stenosis.
2. Patients with a prostatic stone larger than 10 mm in diameter located on the rectal side of the target.
3. Patients with a target located beyond the focal distance (4cm for Sonablate 500).
4. Patients for whom general anesthesia or lumbar anesthesia is not feasible.
5. Patients diagnosed with castration-resistant prostate cancer.
6. Patients who already have urinary incontinence and use urine pads on a daily basis.
7. Patients with a history of diabetes mellitus and poor control (HbA1c >= 8.0 on blood test within 3 months prior to obtaining consent).
8. Patients who have not been off anticoagulants or antiplatelet agents for the period recommended for each agent before and after treatment.
9. Patients with coagulation system disorders and evaluated as difficult to perform surgery within 3 months prior to obtaining consent.
10. Patients who were evaluated as being susceptible to infection within 3 months prior to obtaining consent.
11. Patients with WBC larger than 12000/uL, creatinine larger than 2.0 mg/dL, AST larger than 100IU/L, ALT larger than100 IU/L, or hemoglobin less than 8.0 g/dL on blood test
12. Other patients deemed inappropriate by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Shoji Sunao