Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.
European and American guidelines recommend several therapeutic alternatives: radical surgical treatment, external beam radiotherapy or brachytherapy. However, whole-gland treatment induces significant morbidity and burden on quality of life. Targeted treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment. The purpose of this study is to assess the efficacy of a novel ablation treatment using microwaves, delivered transrectally or transperineally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using Organ Based Tracking (OBT) fusion with the TRINITY system (KOELIS, Meylan, France). The same system will be used to identify the index lesion and guide the targeted microwave ablation performed with the TATO3 device (Biomedical Srl, Florence, Italy). All patients will undergo biopsy at 12 months of follow-up. A biopsy session will also be performed at 6 months, but only for patients with imaging results suspicious for cancer within the ablated area on the mpMRI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach
Institut Jules Bordet
Brussels, Belgium
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
American Hospital of Paris
Neuilly-sur-Seine, France
Hôpital Cochin (Assistance Publique - Hôpitaux de Paris)
Paris, France
The proportion of patients with no evidence of cancer on targeted biopsy
The proportion of patients with no evidence of cancer on targeted biopsy at 12 months, defined by a minimum of 2 targeted core biopsies taken from the index tumor site treated with microwave ablation for focal treatment of intermediate risk prostate cancer
Time frame: 12 months
Proportion of radical salvage treatment
Proportion of patients undergoing radical salvage treatment of the index lesion
Time frame: 12 months
Time to radical salvage treatment
Time to radical salvage treatment of the index lesion
Time frame: 12 months
Proportion of patients with any cancer in the untreated area
Proportion of patients with any cancer in the untreated area, determined by a minimum 12 cores systematic biopsy
Time frame: 12 months
Proportion of patients undergoing treatment for cancer in the untreated area
Proportion of patients undergoing treatment for cancer in the untreated area and time to treatment
Time frame: 12 months
IPSS questionnaire
Changes in patients' reported outcome measures (PROMs) for urinary symptoms using IPSS score compared to baseline, score ranging from 0 to 35 (the higher the worse)
Time frame: 7 days and 1, 6 and 12 months
IIEF-5 questionnaire
Changes in patients' reported outcome measures (PROMs) for erectile function using IIEF-5 score compared to baseline, score ranging from 5 to 25 (the lower the worse)
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Urologie Nantes Clinique & Institut d'Urologie - Site Atlantis
Saint-Herblain, France
Time frame: 7 days and 1, 6 and 12 months
MSHQ-EjD-SF questionnaire
Changes in patients' reported outcome measures (PROMs) for ejaculatory function and bother using MSHQ-EjD-SF score compared to baseline, score ranging from 1 to 15 (the lower the worse) for ejaculatory function and from 0 to 5 for bother/satisfaction (the higher the worse)
Time frame: 7 days and 1, 6 and 12 months
Urine flow
Change in urine flow, using a uroflowmeter compared to baseline
Time frame: 7 days and 1, 6 and 12 months
Adverse events
Number and severity of device and procedure related adverse events
Time frame: 12 months
Patient post-operative pain level
Average patient post-operative pain level reported on a pain numeric rating scale, with a range from 0 (no pain) to 10 (worst pain ever)
Time frame: Treatment day-evaluated between 2 and 4 hours after the procedure
Patient satisfaction
Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)
Time frame: 1, 6 and 12 months
Ease of the procedure
Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)
Time frame: Day 1
Duration of the procedure and associated variables
Duration of the procedure and associated variables
Time frame: Day 1
PSA
Change in PSA measurement compared to baseline
Time frame: 1, 3, 6, 9 and 12 months
PSA Nadir
Time to PSA Nadir after treatment of the index lesion
Time frame: 12 months
Prostate volume
Change in volume of the prostate on the mpMRI compared to baseline
Time frame: 7 days and 6 and 12 months
Patient motivation
Characterization of patient motivation to undergo targeted microwave ablation for treatment of the index lesion, as assessed by patient questionnaire (no score assigned)
Time frame: Baseline
Surgeon opinion regarding adequate guidance of the microwave ablation needle
To evaluate the adequate guidance of the microwave ablation needle by the surgeon opinion
Time frame: Day 1
Adequate guidance of the microwave ablation needle on the treated index lesion
To evaluate the adequate guidance of the microwave ablation needle by percentage of covering of the treated index lesion
Time frame: Day 1
Adequate guidance of the microwave ablation needle on the treated index lesion and margins
To evaluate the adequate guidance of the microwave ablation needle by percentage of covering of the treated index lesion and margins
Time frame: Day 1
Learning curve of the TMA procedure
To evaluate the learning curve of the TMA procedure by the duration of the intervention (delay between probe in and the end of anesthesia (minutes).
Time frame: Day 1