Targeted Microwave Tissue Coagulation for Prostate Cancer

Prostate Cancer Clinical Trial

— MicroPro2  

Official title:

Clinical Trial of Evaluating Efficacy and Safety for Percutaneously Prostate Cancer Lesion Targeted Microwave Tissue Coagulation as Prostate Functional Preservation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430749
• Other study ID #: CTREC-S220202
• Secondary ID: jRCTs052240015
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: May 2024
• Source: Kyoto Prefectural University of Medicine
• Contact: Osamu Ukimura, Professor
• Phone: +81 75 251 5595
• Email: ukimura[@]koto.kpu-m.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial is to provide a minimally invasive treatment option in which the targeted prostate cancer tissue is killed by microwave 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.

Description:

This trial will to provide an ultrasound-guided targeted microwave tissue coagulation of known cancer lesions in patients diagnosed with clinically localized prostate cancer, and this trial will assess efficacy and safety endpoints for up to post-operative 6 months. This trial will assess patient quality of life (QOL) as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: October 31, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patients who have a single lesion of PI-RADS category 3 or 4 lesion on MRI image at enrollment and which is proved as a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a single lesion of PI-RADS category 4 or 5 lesion on MRI image at enrollment and which is proved as 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 which is 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 the rectum is 10 mm or less on MRI images (coronal or sagittal) obtained during enrollment

6. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment

7. Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment

8. Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment

9. Patients with active multiple cancers

10. Patient who wear a pacemaker

11. Patients for whom MRI scans are contraindicated

12. Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum

13. Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment

14. Patients deemed to be ineligible by an investigator

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Microtaze
Targeted Microwave Tissue Coagultion

Locations

Country	Name	City	State
Japan	Kyoto Prefectural University of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Osamu Ukimura

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disappearance of cancer at 6 month after microwave coagulation evaluated by combination of the responses in PSA, MRI, and Prostate biopsy	Achievement of 1) serum marker, 2) imaging, and 3) histopathological examination, below; 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 (Including 'difficult to judge' and 'change after treatment') 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	6 months