An interventional study of The Visual Ice Cryoablation System in Prostate Cancer, sponsored by Osamu Ukimura. Active, not recruiting at 2 sites in Japan. Open to male participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Osamu Ukimura · Not applicable, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 51 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Osamu Ukimura is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.)
Device: The Visual Ice Cryoablation System
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.
Also known as: Targeted focal cryoablation of localized prostate cancer
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 1. A 50% or greater reduction from the preoperative serum PSA level at postoperative 3 or 6 months 2. A reduction of PI-RADS category of the targeted prostate cancer lesion down to 3 or lower at MRI images at postoperative 6 months 3. No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy of the prostate performed at postoperative 6 months
Time frame: 6 months after the cryosurgery
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Osamu Ukimura