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Prostatic Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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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

Targeted prostate biopsy

Transperineal ultrasound guided prostate biopsy(SB).

Standard biopsy

Hongqian Guo, PhD

Jie Gao, Bachelor

Jie Gao, MD

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of mpMRI-targeted biopsy compared to transperineal standard biopsy in men with clinical suspicion of prostate cancer who had no prior prostate biopsy.

Prostate biopsy with multiple samples using a standardized template (standard biopsy, SB) under transrectal ultrasound (TRUS) guidance is the current standard diagnostic approach in suspicion of prostate cancer (PCa). However, many biopsies are unnecessary or cannot detect clinically significant PCa (csPCa).

With the introduction of multiparametric magnetic resonance imaging (mpMRI) of the prostate and the improvement for PCa detection and localization, an alternative procedure, known as MRI-targeted biopsy (TB), has been shown comparable or even higher detection rates of csPCa compared to TRUS-biopsy (SB).

This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of TB compared to SB (transperineal) in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.

Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection

Diagnostic Efficiency With Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Transperineal Ultrasound-guided Biopsy in Biopsy-naïve Suspicious Prostate Cancer Patients: A Randomized Controlled Trial

Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.

Clinically insignificant prostate cancer is considered as: biopsy Gleason score \<3+4 and maximum cancer core length \<5 mm.

Comparing the Gleason grades (from 1-5, the bigger the worse) between biopsy and final pathology, Gleason grade is upgrading when the Gleason grade of final pathology is bigger than that of biopsy.

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Executive officer of Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Erythema Multiforme

Erythema

Skin Diseases

Skin Diseases, Vesiculobullous

Ingrid Millet, PUPH

Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).

Prostate Biopsies With Target Lesion on MRI

Prostate Biopsies With Target Lesion on MRI : When Can Non-targeted Biopsies be Dispensed With

Non-targeted biopsy not finding cancer of finding cancer of a grade lower than or egal to that found on targeted biopsies

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
Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection	NCT03572946	Prostate Neopla...	Targeted prosta... Standard biopsy	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Targeted Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection	NCT03572946	Prostate Neopla...	Targeted prosta... Standard biopsy	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Prostate Biopsies With Target Lesion on MRI	NCT04692207	Prostate Cancer		18 Years -	University Hospital, Montpellier
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 Biopsy or Standard Biopsy for Clinical Significant Prostate Cancer Detection	NCT03572946	Prostate Neopla...	Targeted prosta... Standard biopsy	18 Years -	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Spots Global Cancer Trial Database for targeted prostate biopsy