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Brief Title: Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial
Official Title: Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated Trial
Study ID: NCT05500846
Brief 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.
Detailed Description: 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University Hospital, Kyoto Prefectural University of Medicine, Kyoto, , Japan
Kyoto Miniren Chuo Hospital, Kyoto, , Japan
Name: Osamu Ukimura, M.D., Ph.D.
Affiliation: Department of Urology, University Hospital, Kyoto Prefectural University of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Toshiko Ito-Ihara, M.D., Ph.D.
Affiliation: The Clinical and Translational Research Center , University Hospital, Kyoto Prefectural University of Medicine (CTREC)
Role: STUDY_CHAIR