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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

Symptoms and General Pathology

Recurrence

Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins

FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

CIELO D GUERRA, BS

LUANDA SIANO, PA

FERNANDO J BIANCO, MD

EDWARD L GHEILER, MD

ARIEL M KAUFMAN, MD

EUSEBIO J LUNA, MD

EUSEBIO LUNA, MD

Isabel H Lopez, MD

Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

CLINICAL TRIAL OF OBSERVATION NATURE

PRIMARY OUTCOME

Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival

SECONDARY OUTCOMES

Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care

DATA COLLECTION

* Complete H\&P, family history, past medical and surgical history, social history, allergies, and medications
* As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
* Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
* Procedure specific Co-Registration quality with ultrasound denoting quality
* Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at neurovascular bundles, denonvilliers fascia. Urethral warmer requirements
* Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual Function inventories, Overall anxiety and regret related to diagnosis and treatment
* Uroflow and PVR measurements by 3 to 6 month of treatment
* MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new suspicious MRI findings
* MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis
* Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas, suspicious MRI areas
* Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas, suspicious MRI areas
* 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan

SAFETY MEASURES

* Periodic evaluation of registry to ensure consistency in follow up
* Patient remainders of tests required

MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions

Type of treatments required after initial intervention over time

Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy

Lack of prostate cancer presence in gland measured by MP-MRI

Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals

Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel

Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
MRI/Ultrasound Fusion Guided Prostate Cryotherapy	NCT02381990	Neoplasms Prost... Cancer of the P...	FUSE IMAGE MRI ...	55 Years -	Urological Research Network, LLC
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
MRI/Ultrasound Fusion Guided Prostate Cryotherapy	NCT02381990	Neoplasms Prost... Cancer of the P...	FUSE IMAGE MRI ...	55 Years -	Urological Research Network, LLC

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