Microwave Needle Thermoablation for Treatment of Localized Prostate Cancer

NCT04113811 | Completed

• 1 other identifier: CRE 2019.347
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the surrounding organs like rectum and bladder. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the target lesion without treating other benign areas, resulting in disease cure in majority of cases with less treatment morbidity. Microwave treatment to the prostate has been performed since more than 20 years ago for benign prostatic hyperplasia and is approved by FDA in United States. It exerts its effect through thermal destruction of prostate tissue. Targeted treatment of localized prostate cancer using microwave needle ablation guided by MRI and Ultrasound imaging has been performed recently and was shown to be safe and effective. Our study aims to assess the effectiveness of this focal therapy in treating localized prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Focal therapy; Microwave ablation

Outcome Measures

Primary Outcomes (1)

• The oncological control of prostate cancer

  Any cancer detected on biopsy of each ablated area

  At 6 months after treatment

Secondary Outcomes (14)

• Per-patient analysis of any cancer detected on biopsy of any ablated areas

  At 6 months after treatment

• Cancer detection on biopsy of each ablated MRI visible lesion

  At 6 months after treatment

• Cancer detection on biopsy of each ablated MRI invisible lesion

  At 6 months after treatment

• Gleason 4 or 5 cancer detected on biopsy of ablated area

  At 6 months after treatment

• Out-of-field recurrence: Any cancer outside treated area on systematic biopsy

  At 6 months after treatment

Study Arms (1)

Microwave needle thermoablation of prostate cancer

EXPERIMENTAL

The treatment will be performed under general anaesthesia or monitored anaesthetic care using the Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) under Organ-based Tracking® (OBT) mechanism of the Koelis Trinity® machine. Both Koelis Trinity and TATO3 are CE (European Conformity) marked in Europe. A transrectal sideview ultrasound probe is used for real-time imaging and OBT of the prostate. The TATO3® needle is inserted transperineally to the tumor under MRI-Ultrasound fusion OBT guidance with the treatment zone covering the whole tumor. The dominant MRI-visible lesion and up to 1-2 more MRI-visible or invisible lesion will be treated.

Device: Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)

Interventions

Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France) DEVICE

In this study, we plan to investigate oncological outcome of fusion-guided microwave needle therapy using transperineal (TP) approach

Microwave needle thermoablation of prostate cancer

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men aged between 45 - 75 years
• Life expectancy \> 10 years upon recruitment
• Localized low or intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy
• Organ-confined prostate cancer on MRI
• PSA \< 20 ng/mL
• At least 1 MRI visible lesion present and size ≤15mm, and Targeted biopsy showing Gleason score 6 (with cancer core length ≥6mm) or Gleason score 7 (3+4 or 4+3), With or without positive Systematic biopsy (out of 24 systematic cores) away from MRI visible target showing Gleason 6 cancer

You may not qualify if:

• Patients unfit for MRI exam or MR gadolinium contrast
• Patients with previous treatment of prostate cancer
• Patients with maximal length of target lesion \>15mm
• Patients with MRI-visible or invisible lesion within 10mm from rectum or 10mm from sphincter on MRI
• Patients with \>3 areas (MRI-visible or invisible) of prostate cancer
• Patients with Gleason score 4+4 or any Gleason pattern 5 cancer
• Patients with bladder pathology including bladder stone and bladder cancer
• Patients with urethral stricture
• Patients with neurogenic bladder and/or sphincter abnormalities

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (17)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter KF Chiu, MBChB,FRCSEd

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a single-centre prospective phase 2 trial to investigate the efficacy of Microwave needle thermoablation of prostate cancer using the Biomedical TATO3® (Thermal Ablation Treatments for Oncology 3) ablation system in patients with localized prostate cancer.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: October 8, 2019
• Primary Completion: February 16, 2023
• Study Completion: April 11, 2023
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)