Targeted Microwave Focal Therapy

NCT04627896 | Completed Phase 2

• 1 other identifier: 0005732
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Focal therapy (FT) for prostate cancer (PCa) is an interesting therapeutic option for localized disease with a favorable low- to intermediate-risk profile. The aim of this approach is to offer a personalized and less aggressive treatment as compared to radical treatments such as radical prostatectomy (RP) or primary radiation therapy, reducing functional morbidity while maintaining oncologic efficiency. FT is based on the treatment of a part of the prostate, containing the index lesion. The index lesion is identified as a single visible lesion up to 12 mm at multiparametric MRI (mpMRI), which is biopsied with a fusion biopsy obtaining a Gleason score inferior or equal to 3+4. These features allow a focal treatment aimed to ablate the area containing the tumor. In case of a concomitant presence of 1 or 2 cores of Gleason score 3+3 found at systematic biopsy and invisible to mpMRI, a strategy of surveillance will be adopted, focusing the treatment only on the index lesion (only in patients older than 70 years old). Different sources of energy have been used to date for focal therapy. Among these, has emerged a very low loss (VLL) microwave ablation system, called TATO3®, specifically developed to work with the fusion biopsy platform Koelis Trinity® that allows an accurate 3D reconstruction of the prostate, with the goal to offer a targeted treatment after a targeted biopsy. Aim of this experimental trial is to evaluate the efficacy of the Trinity®-guided TATO3® treatment in the ablation of the index lesion, together with the safety of the procedure and the short-term oncologic outcomes.

Conditions

Prostate Cancer Stage I

Outcome Measures

Primary Outcomes (1)

• Complete tumor ablation

  absence of tumor at the site of treatment in the repeated targeted biopsies at 6 months.

  6 months after treatment

Secondary Outcomes (3)

• Gleason score pattern 4 tumor ablation

  6 months after treatment

• Functional score IPSS

  1 week, 1 month, 3 months, 6 months after treatment

• Functional score IIEF-5

  1 week, 1 month, 3 months, 6 months after treatment

Study Arms (1)

Katty focal therapy

EXPERIMENTAL

Patients fulfilling inclusion criteria undergo focal treatment with Trinity-guided Katty device

Device: Katty focal therapy

Interventions

Katty focal therapy DEVICE

Microwave ablation with TATO3 generator (Katty system) under guidance of ultrasound/mpMRI fusion image device Trinity

Katty focal therapy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 45 to 80 years old, with 10 years life expectancy
• WHO Performance status 0 or 1
• Newly diagnosis of low to intermediate-risk PCa, defined by T1c or T2a clinical stage, PSA rate \<20 ng/ml, unique clinically significant cancer focus visible on mpMRI, scored as ISUP grade group 1 (Gleason score 3+3) or 2 (Gleason score ≤3+4), up to 12 mm in diameter (index lesion). This focal treatment does not intend to replace active surveillance: in the cases where the indications are common to both options, focal treatment will be offered as a viable alternative to those patients unwilling to undergo active surveillance.
• All patients must have been diagnosed with transrectal or transperineal targeted and systematic biopsies performed with Koelis Trinity® system
• The presence of up to 2 additional cores of Gleason score 3+3 detected on systematic biopsies and invisible to mpMRI (therefore considered as non-significant lesions) is allowed in patients ≥70 years old: these lesions will be put under surveillance, as per regional protocol called START.
• Patient accepting to be followed after the study
• Free, informed and written consent

You may not qualify if:

• Past medical history of prostate radiotherapy or pelvic trauma
• Presence of other concomitant cancers
• Diagnosis of chronic prostatitis as defined by EAU guidelines
• Severe benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms, defined by an IPSS score \>18
• Inability to perform mpMRI
• Suspicion of extracapsular extension or seminal vesicles invasion on mpMRI
• Tumor largest axis \>12 mm on mpMRI
• Distance between cancer focus and apex \<5 mm on the prostate MRI
• Distance between cancer focus and rectum \<5 mm on the prostate MRI
• Presence of one or more other clinically significant cancer foci, beyond the index lesion, scored as Gleason ≥7.
• Presence of more than two additional cores of Gleason score 6 (3+3) on systematic biopsies, beyond the index lesion
• Patients undergone biopsy with a system other than Koelis Trinity®
• Patients already participating in a clinical trial

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• Koelis: collaborator

Study Sites (1)

A.O.U. San Giovanni Battista Molinette

Torino, TO, 10126, Italy

Location

Related Publications (5)

• Sanchez-Salas R, de la Rosette J, Polascik TJ, Carneiro A, Sivaraman A, Cathelineau X, Walz J. Focal Therapy for Prostate Cancer: A More Vehement View of the Approach Could Translate into Real Benefits for Our Patients. Eur Urol. 2018 Nov;74(5):537-539. doi: 10.1016/j.eururo.2018.04.018. Epub 2018 May 1.

  PMID: 29724502 RESULT

• Barbalias GA, Liatsikos EN. Transrectal microwave hyperthermia for patients with benign prostatic hyperplasia. Int J Urol. 1998 Mar;5(2):157-62. doi: 10.1111/j.1442-2042.1998.tb00267.x.

  PMID: 9559842 RESULT

• Sherar MD, Gertner MR, Yue CK, O'Malley ME, Toi A, Gladman AS, Davidson SR, Trachtenberg J. Interstitial microwave thermal therapy for prostate cancer: method of treatment and results of a phase I/II trial. J Urol. 2001 Nov;166(5):1707-14. doi: 10.1016/s0022-5347(05)65658-3.

  PMID: 11586207 RESULT

• Oderda M, Marra G, Albisinni S, Altobelli E, Baco E, Beatrici V, Cantiani A, Carbone A, Ciccariello M, Descotes JL, Dubreuil-Chambardel M, Eldred-Evans D, Fasolis G, Ferriero M, Fiard G, Forte V, Giacobbe A, Kumar P, Lacetera V, Mozer P, Muto G, Papalia R, Pastore A, Peltier A, Piechaud T, Simone G, Roche JB, Roupret M, Rouviere O, Van Velthoven R, Gontero P. Accuracy of elastic fusion biopsy in daily practice: Results of a multicenter study of 2115 patients. Int J Urol. 2018 Dec;25(12):990-997. doi: 10.1111/iju.13796. Epub 2018 Sep 5.

  PMID: 30187529 RESULT

• Schepps JL, Foster KR. The UHF and microwave dielectric properties of normal and tumour tissues: variation in dielectric properties with tissue water content. Phys Med Biol. 1980 Nov;25(6):1149-59. doi: 10.1088/0031-9155/25/6/012.

  PMID: 7208627 RESULT

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

• Marco Oderda, MD, PhD

  A.O.U. Città della Salute e della Scienza di Torino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Targeted microwave ablation

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: November 13, 2020
• Study Start: November 9, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)