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

NCT05500846 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-06-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Osamu Ukimura

    lead OTHER

Principal Investigators

  • Osamu Ukimura, M.D., Ph.D. · Department of Urology, University Hospital, Kyoto Prefectural University of Medicine

  • Toshiko Ito-Ihara, M.D., Ph.D. · The Clinical and Translational Research Center , University Hospital, Kyoto Prefectural University of Medicine (CTREC)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2023-11-14
Completion
2024-12-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500846 on ClinicalTrials.gov