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| ID | Type | Description | Link |
|---|---|---|---|
| jRCTs052240015 | Other Identifier | Japan Registry of Clincal Trials |
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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.
This trial will provide ultrasound-guided targeted microwave tissue coagulation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and it will assess efficacy and safety endpoints for up to six months post-operatively. This trial will also assess patient quality of life (QOL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microwave Tissue Coagulation Arm | Experimental | The Minimally invasive microwave coagulation surgery will be performed under general anesthesia for aiming to be provided total 65 patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microtaze | Device | Targeted Microwave Tissue Coagulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving disappearance of cancer | Disappearance of cancer is defined with the following criteria:
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Ukimura, Professor | Kyoto Prefectural University of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoto Prefectural University of Medicine | Kyoto | Kyoto | 602-8566 | Japan |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Single Group Assignment
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |