Pilot study of microwave coagulation therapy for localized prostate cancer

JRCT ID: jRCTs052190026

Registered date:17/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prostate cancer
• Date of first enrollment: 18/06/2019
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Pilot clinical trial of targeted therapy for localized prostate cancer

Outcome(s)

• Primary Outcome: Expression of adverse events

Secondary Outcome

Quality of life
cancer control (effects on cancer control by MRI image)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 85age old
• Gender: Male

Include criteria

[1] Localization of cancer lesions was confirmed (limited to one side or confined to the front side in MRI imaging technology of prostate cancer and 3-dimensional real-time ultrasonic guided needle biopsy technology) In the histological diagnosis of cancer, it is "case of cancer lesion to be clinically treated"
[2] Cases with distant distance (> 5 mm) from cancer and neighboring organs (especially urethral sphincter related to urinary prohibition and neurovascular bundle including erectile nerve)
[3] A case with PS (ECOG) 0-1
[4] Age: 50-85
[5] A case who have written informed consent before enrollment in the study

Exclude criteria

1) Patients with distant metastasis detected by CT and bone scintigraphy
2) Patients with tumors in contact with the rectal wall (to avoid rectal thermal damage during microwave coagulation)
3) Patients with pacemakers (to avoid the risk of microwave interference)
4) Patients who cannot undergo transrectal ultrasound because the rectum is closed
5) Patients with coagulation abnormalities (prothrombin time <50% or platelet count <60,000 / mm3) or taking anti-thrombotic drugs and related drugs cannot be withdrawn
Patient
6) Patients with contraindications for MRI pretreatment, MRI, and contrast MRI
7) In the past, pharmacotherapy for prostate cancer (in the case of drugs with hormonal effects, judge at the end of the hormonal effect) and radiation therapy
Patient who performed
8) Patients who have been treated with anti-androgenic hormone for benign prostatic hyperplasia in the past
9) Patients with active double cancer
10) Patients whose main organ functions are not maintained (Severe ECG abnormalities, severe arrhythmias, angina pectoris, heart failure, myocardial infarction)
11) Patients with uncontrollable infections (including hepatitis and active tuberculosis)
12) Patients with severe mental illness
13) Other patients who are judged to be ineligible by the principal investigator

Related Information

• Primary Sponsor: Ukimura Osamu