Actively Recruiting
Targeted Microwave Tissue Coagulation for Prostate Cancer
Led by Osamu Ukimura · Updated on 2024-06-24
65
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by microwave only in the specific area of cancer "that should be treated for saving of life," while leaving a portion of the normal prostate tissue that is not cancerous. This treatment is named "focal therapy" for "clinically localized prostate cancer." As this new treatment aims to treat only the specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is both to control the known cancer by treating only the cancerous area and to maintain the quality of life (QOL) by leaving the other normal prostate tissue and its surrounding organs intact, resulting in the prevention of urinary leakage and sexual dysfunction as complications.
CONDITIONS
Official Title
Targeted Microwave Tissue Coagulation for Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 20 to 85 years at consent
- Single prostate cancer lesion with MRI PI-RADS category 3 or 4 and Gleason score 7 or 8 on biopsy, or MRI PI-RADS category 4 or 5 and Gleason score 6 or 7 on biopsy
- Clinical stage T2c or lower prostate cancer (T1a-T2cN0M0) at enrollment
- Provided informed consent before enrollment
You will not qualify if you...
- Lesion identified as MRI PI-RADS 4 or 5 with diameter less than 10 mm and Gleason score 6 on biopsy
- Four or more non-target lesions (PI-RADS 3 with Gleason score 6 or lesions as defined above)
- Lesion with MRI PI-RADS 5 and Gleason score 8 on biopsy
- Serum PSA level over 20 ng/ml at enrollment
- Distance from target lesion to rectum 10 mm or less on MRI
- Prior antiandrogen treatment for benign prostatic hyperplasia
- Prior surgery, drug, or radiation therapy for prostate cancer
- Active multiple cancers
- Presence of pacemaker
- Contraindications to MRI scans
- Inability to perform transrectal ultrasound, such as due to rectal constriction
- Prothrombin time less than 50% or platelet count less than 60,000/mm3 at enrollment
- Deemed ineligible by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Actively Recruiting
Research Team
O
Osamu Ukimura, Professor
CONTACT
T
Toshiko Ito-Ihara, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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