Minimally invasive microwave treatment for prostate cancer

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

This study is testing a new microwave treatment for men with localized prostate cancer to see if it can safely destroy cancer cells while keeping healthy tissue intact and improving their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 65 (estimated)
• Ages: 20 Years to 85 Years
• Sex: Male
• Sponsor: Kyoto Prefectural University of Medicine (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Kyoto)
• Trial ID: NCT06430749 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a new minimally invasive treatment called targeted microwave tissue coagulation for patients with clinically localized prostate cancer. The approach focuses on destroying only the cancerous tissue while preserving surrounding healthy prostate tissue, aiming to reduce complications such as urinary leakage and sexual dysfunction. Patients will undergo ultrasound-guided treatment, and the study will assess both the efficacy and safety of the procedure, as well as its impact on quality of life over a six-month period post-treatment.

Who should consider this trial

Good fit: Ideal candidates include men aged 20 to 85 with a single prostate cancer lesion classified as PI-RADS category 3 or 4 and a Gleason score of 6 to 8.

Not a fit: Patients with very small lesions (less than 10 mm) or those with a Gleason score of 6 and PI-RADS category 4 or 5 may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a less invasive option for prostate cancer patients, improving their quality of life while effectively managing the disease.

How similar studies have performed: Other studies have shown promise with focal therapy approaches for prostate cancer, indicating potential for success with this novel microwave technique.

Eligibility criteria

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

Where this trial is running

Kyoto

• Kyoto Prefectural University of Medicine — Kyoto, Japan (Recruiting)

Study contacts

• Principal investigator: Osamu Ukimura, Professor — Kyoto Prefectural University of Medicine
• Study coordinator: Osamu Ukimura, Professor

Conditions Prostate Cancer