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

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

NCT ID: NCT05500846

Condition: Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
Prostate Cancer
Localized Prostate Cancer
CISca, Clinically Insignificant Prostate Cancer
CSCa, Clinically Significant Prostate Cancer
Focal Therapy
Treatment of partial prostate
Cryotherapy
Cryosurgery
Targeted Cryoablation
Ultrasound guided surgery
Targeted Prostate Biopsy
MRI, Magnetic Resonance Imaging
PSA, Prostate Specific Antigen
QOL, Quality of Life

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: The Visual Ice Cryoablation System
Description: 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.
Arm group label: Cryoablation Arm

Other name: Targeted focal cryoablation of localized prostate cancer

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Patients who have a PI-RADS category 3 or 4 lesion on MRI image at enrollment and who have a single lesion with a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a PI-RADS category 4 or 5 lesion on MRI image at enrollment and who have a single lesion with a Gleason score 6 or 7 on histopathology of the prostate needle biopsy at enrollment 2. Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment 3. Patients between the ages of 20 and 85 when providing consent to participate in this trial 4. Patients from whom consent is obtained prior to enrollment in this trial Exclusion Criteria: 1. Patients to have a lesion identified as PI-RADS category 4 or 5 on MRI images at enrollment and who have a single lesion with a diameter of less than 10 mm and Gleason score of 6 on the histopathology of the prostate needle biopsy at enrollment (the lesion is referred to as "non-target lesions") (the diameter of the lesion is defined as the longer one of the lesion diameter identified on MRI images at enrollment or the tumor length as measured on histopathology of prostate needle biopsy) 2. Patients to have 4 or more non-target lesions (non-target lesions are defined as the lesions defined in exclusion criterion 1, or lesions with PI-RADS category 3 on MRI image at enrollment and Gleason score 6 on biopsy at enrollment) 3. Patients to have a lesion with PI-RADS category 5 on MRI image at enrollment and Gleason score 8 on histopathology of prostate needle biopsy at enrollment (the lesion is referred "excluded lesions") 4. Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment 5. Patients in whom the distance from the target prostate cancer lesion to an external urinary sphincter is 5 mm or less on MRI images (coronal or sagittal) obtained during enrollment 6. Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment 7. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment 8. Patients using absorbent pads or adult diapers due to urge incontinence 9. Patients with active multiple cancers 10. Patients for whom MRI scans are contraindicated 11. Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum 12. Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment 13. Patients deemed to be ineligible by an investigator

Gender: Male

Gender based: Yes

Gender description: Because the prostate is an organ that only men have.

Minimum age: 20 Years

Maximum age: 85 Years

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital, Kyoto Prefectural University of Medicine

Address:
City: Kyoto
Zip: 602-8566
Country: Japan

Facility:
Name: Kyoto Miniren Chuo Hospital

Address:
City: Kyoto
Zip: 616-8147
Country: Japan

Start date: October 19, 2021

Completion date: December 31, 2024

Lead sponsor:
Agency: Osamu Ukimura
Agency class: Other

Source: Kyoto Prefectural University of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05500846