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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.)

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.

The Visual Ice Cryoablation System

Osamu Ukimura, M.D., Ph.D.

Toshiko Ito-Ihara, M.D., Ph.D.

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.

Because the prostate is an organ that only men have.

Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial

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

Osamu Ukimura

Professor, Department of Urology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial	NCT05500846	Prostate Cancer	The Visual Ice ...	20 Years - 85 Years	Kyoto Prefectural University of Medicine
Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial	NCT05500846	Prostate Cancer	The Visual Ice ...	20 Years - 85 Years	Kyoto Prefectural University of Medicine

Spots Global Cancer Trial Database for the visual ice cryoablation system