Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion

Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach

Targeted microwave ablation

Damien FONTANELLI, MSc

Alexandre PELTIER, MD

Franck BLADOU, MD

Aurel MESSAS, MD

Pierre MOZER, MD

Nicolas BARRY DELONGCHAMPS, MD

Eric POTIRON, MD

Bernard MALAVAUD, MD

Roland VAN VELTHOVEN, MD

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.

Multicenter, single-arm, open-label, 12-month follow-up clinical trial

Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer

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

Proportion of patients undergoing radical salvage treatment of the index lesion

Time to radical salvage treatment of the index lesion

Proportion of patients with any cancer in the untreated area, determined by a minimum 12 cores systematic biopsy

Proportion of patients undergoing treatment for cancer in the untreated area and time to treatment

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)

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)

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)

Change in urine flow, using a uroflowmeter compared to baseline

Number and severity of device and procedure related adverse events

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)

Patient satisfaction with the microwave ablation procedure as determined by questionnaire (no score assigned)

Ease of the procedure measured with a score chosen by the operator (1: easy, 2: moderate, 3: difficult)

Duration of the procedure and associated variables

Change in PSA measurement compared to baseline

Time to PSA Nadir after treatment of the index lesion

Change in volume of the prostate on the mpMRI compared to baseline

Characterization of patient motivation to undergo targeted microwave ablation for treatment of the index lesion, as assessed by patient questionnaire (no score assigned)

Spots Global Cancer Trial Database for targeted microwave ablation