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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2052210088 | 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 cryoablation at extremely low temperatures 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. It is a treatment, named by "focal therapy" for "clinically localized prostate cancer". As this new treatment is aiming to treat only specific prostatic area of cancer, it is different from the invasive conventional treatment to remove the entire prostate gland. The goal is to achieve both to control of known cancer by treating only the cancerous area and to maintain of QOL (Quality-of-life) by leaving of the other normal prostate tissue and its surrounding organs intact resulting in prevention of urinary-leakage and sexual-dysfunction as the complications.
This trial will to provide an ultrasound-guided targeted cryoablation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and this trial will assess effectiveness for up to post-operative 6 months and safety for up to postoperative 12 months. This trial will assess patient quality of life (QOL) as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoablation Arm | Experimental | Minimally invasively trans-perineal puncture of both cryo-needles and temperature-needles will be placed under real-time image guidance to the targeted area of cancer lesion or temperature-monitoring sites, respectively. The targeted tissue surrounding the tip of cryo-needles will be freeze down to targeted temperature for killing the cancer cells, and other non-treated area will be left in the prostate for aiming of maintain QOL (quality-of-life). The Minimally invasive cryoablation surgery will be performed under general anesthesia within one and half hour for aiming to be provided total 50 patients. (The used device for this arm has been clinically approved for cryoablation of renal cancer in Japan.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Visual Ice Cryoablation System | Device | Currently, the standard surgical treatment option for localized prostate cancer is total prostatectomy, which removes the entire prostate organ. However, total prostatectomy is invasive and postoperative urinary incontinence, sexual dysfunction and local recurrence remain clinical challenges even with the introduction of robotic assistance techniques. Cryotherapy has been approved as one of the other surgical treatment options for localized prostate cancer in the USA and Europe, but not in Japan. This clinical trial aims to expand the indication of cryotherapy equipment, which has already been approved for insurance for renal cancer, to prostate cancer in Japan. In this clinical trial, Focal Therapy will be performed by targeting a single localized prostate cancer lesion visualized by MRI. By targeting cancer lesions in a minimally invasive manner, we aim to achieve both control of cancer lesions and maintenance of quality of life. |
| Measure | Description | Time Frame |
|---|---|---|
| Disappearance of cancer at 6 month after cryosurgery evaluated by combination of the responses in PSA, MRI, and Prostate biopsy | Achievement of all endpoints in the three clinical parameters including 1) reduction of serum PSA value, 2) reduction of PI-RADS category for MRI-visible lesion, and 3) histological disappearance of cancer by prostate biopsy
| 6 months after the cryosurgery |
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Inclusion Criteria:
Exclusion Criteria:
Because the prostate is an organ that only men have.
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Ukimura, M.D., Ph.D. | Department of Urology, University Hospital, Kyoto Prefectural University of Medicine | Principal Investigator |
| Toshiko Ito-Ihara, M.D., Ph.D. | The Clinical and Translational Research Center , University Hospital, Kyoto Prefectural University of Medicine (CTREC) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan | |||
| Kyoto Miniren Chuo Hospital |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Kyoto |
| 616-8147 |
| Japan |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |