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

Primary Purpose

Prostate Cancer

Status

Active

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

The Visual Ice Cryoablation System

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring 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

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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
Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment
Patients between the ages of 20 and 85 when providing consent to participate in this trial
Patients from whom consent is obtained prior to enrollment in this trial

Exclusion Criteria:

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)
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)
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")
Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment
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
Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment
Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
Patients using absorbent pads or adult diapers due to urge incontinence
Patients with active multiple cancers
Patients for whom MRI scans are contraindicated
Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum
Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment
Patients deemed to be ineligible by an investigator

Sites / Locations

University Hospital, Kyoto Prefectural University of Medicine
Kyoto Miniren Chuo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoablation Arm

Arm Description

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.)

Outcomes

Primary Outcome Measures

Disappearance of cancer at 6 month after cryosurgery evaluated by combination of the responses in PSA, MRI, and Prostate biopsy

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 A 50% or greater reduction from the preoperative serum PSA level at postoperative 3 or 6 months A reduction of PI-RADS category of the targeted prostate cancer lesion down to 3 or lower at MRI images at postoperative 6 months No cancer tissue in histopathological examination from the targeted prostate cancer lesion via a needle biopsy of the prostate performed at postoperative 6 months

Secondary Outcome Measures

Full Information

NCT ID

NCT05500846

First Posted

August 11, 2022

Last Updated

May 19, 2023

Sponsor

Osamu Ukimura

1. Study Identification

Unique Protocol Identification Number

NCT05500846

Brief Title

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

Acronym

PROCRY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

February 29, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Osamu Ukimura

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cryoablation Arm

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

The Visual Ice Cryoablation System

Other Intervention Name(s)

Targeted focal cryoablation of localized prostate cancer

Intervention 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.

Primary Outcome Measure Information:

Title

Disappearance of cancer at 6 month after cryosurgery evaluated by combination of the responses in PSA, MRI, and Prostate biopsy

Description

Time Frame

6 months after the cryosurgery

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Because the prostate is an organ that only men have.

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment Patients between the ages of 20 and 85 when providing consent to participate in this trial Patients from whom consent is obtained prior to enrollment in this trial Exclusion Criteria: 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) 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) 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") Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment 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 Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment Patients using absorbent pads or adult diapers due to urge incontinence Patients with active multiple cancers Patients for whom MRI scans are contraindicated Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment Patients deemed to be ineligible by an investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osamu Ukimura, M.D., Ph.D.

Organizational Affiliation

Department of Urology, University Hospital, Kyoto Prefectural University of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Toshiko Ito-Ihara, M.D., Ph.D.

Organizational Affiliation

The Clinical and Translational Research Center , University Hospital, Kyoto Prefectural University of Medicine (CTREC)

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital, Kyoto Prefectural University of Medicine

City

Kyoto

ZIP/Postal Code

602-8566

Country

Japan

Facility Name

Kyoto Miniren Chuo Hospital

City

Kyoto

ZIP/Postal Code

616-8147

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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