Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04627896
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2020-02-16
Brief Title:
Targeted Microwave Focal Therapy
Sponsor:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Organization:
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Study Overview
Official Title:
Safety and Efficacy of a Novel 3D Cartography-based Targeted Microwave Focal Therapy Device in Men With Localized Low to Intermediate-risk Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 34 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 33 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
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 34 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 33 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
Detailed Description:
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 Over 90 of PCa are multifocal and unilateral disease is estimated to be present in only 20-40 of patients Despite the multifocal nature of PCa many affected men have just a single substantial lesion which is called index lesion Ohori et al determined that up to 80 of PCa volume arises through the index lesion Clinically vast evidence indicates that the index lesion features predict the behavior of the disease Indeed risk stratification of the index lesion predicts PCa outcomes irrespectively from the presence of unilateral or bilateral disease and most metastatic PCa arise from the cell clone of the index lesion FT relies on the concept that residual PCa in the untreated area does not compromise long-term disease control given that it falls into the criteria of active surveillance The success of focal therapy strongly depends on the ability to detect the foci of PCa through multiparametric magnetic resonance imaging mpMRI which has gained a paramount role in PCa diagnosis Clinically significant prostatic lesions have features detectable at mpMRI and can be targeted with fusion biopsies which combine the data coming from mpMRI and transrectal ultrasound TRUS imaging Data from PROMIS trial demonstrated MRI sensitivity of 93 for clinically significant cancer and a meta-analysis by Moldovan et al showed a negative predictive value of mpMRI of 881 A European consensus meeting suggested that mpMRI in combination of a systematic sampling achieves a negative predictive value of 90-95 Bearing in mind the limitations of the mpMRI however to-date systematic biopsies are mandatory to ensure the most accurate sampling possible and any FT performed should consider a reasonable security margin
For a successful treatment patient selection is essential Currently the ideal candidates for FT should be patients harboring intermediate-risk PCa with favorable features and a limited component of Gleason score pattern 4 A 2015 consensus meeting stated that providing FT to patients with low-risk prostate cancer would represent overtreatment in men suitable for active surveillance Furthermore candidates for FT must have a life expectancy of more than 5 years and a WHO performance status of 0 or 1 In the last years FT has solidly evolved from low-risk to intermediate-risk disease since the first FT trials more than 2700 patients have been treated and this approach is now at the level of exploration of indications quality control measures and reproducibility in larger trials In 2017 a randomized controlled trial RCT has shown the potential benefits of FT versus active surveillance in low-risk PCa in terms of cancer progression secondary treatments and negative biopsies at 2-yrs follow-up In intermediate-risk PCa another RCT of partial prostate ablation versus RP has completed the feasibility phase the main study is set up with the goal to prove the benefit of FT versus RP in terms of PCa mortality In line with the recommendations of the 2015 consensus meeting the investigators believe that suitable candidates for FT are those with a single small focus of Gleason score 7 34 PCa with possible limited adjunctive presence of clinically insignificant foci of Gleason score 6 33 invisible to mpMRI When speaking of FT for PCa several energy modalities have been developed including high-frequency ultrasound HIFU cryotherapy laser interstitial thermotherapy photodynamic therapy irreversible electroporation brachytherapy and radiofrequency ablation To date studies were able to prove the feasibility low morbidity profile and satisfying short- and medium-term oncologic results of FT mainly based on imaging and rebiopsy Nevertheless according to the last European Association of Urology EAU guidelines FT is still considered experimental to be offered within a clinical trial Recently among energy modalities has emerged also 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
Since the 1980s microwaves have been widely used for the treatment of Benign Prostatic Hyperplasia BPH Low intensity energy is applied to the entire organ to reduce the volume of the gland Several studies have shown the safety of microwaves propagation through the prostate with transurethral transperineal and transrectal accesses while variable results have been achieved in terms of prostate volume reduction
The treatment of PCa by microwaves requires the use of higher energy as compared to BPH treatment in order to irreversibly denature tumor cells A phase III clinical has been led since 1998 to investigate the safety and efficacy of transperineal microwave therapy for recurrent PCa following external beam radiation therapy A preliminary result on 25 patients has shown a very low complication rate following the treatment and good oncological results Six months after the treatment 64 of the biopsy result were negative On the last update of 2004 with 41 patients enrolled no serious complications were observed as a result of the procedure and although mild continence problems were encountered these were generally temporary
TATO3 VLL microwave ablation system represents the last evolution in the field of microwave treatment for PCa Following dry lab testing it has been experimented in the animal setting on dogs More recently it has been used at Hôpital Cochin Paris in the setting of clinical study where preliminary results on 10 patients with low risk PCa showed an excellent safety profile of targeted focal microwave treatment for the ablation of index tumor Final results are awaited this summer Another study is ongoing in at Erasme Hospital Brussels treating patients already scheduled for radical prostatectomy with the aim of examining the extension of the treated area and confirming the absence of cancerous cells To-date the treatment is well tolerated and efficacious
Since 2015 the investigators have acquired a significant expertise in the field of prostate fusion biopsies achieving outstanding cancer detection rates and improving the risk stratification of newly diagnosed PCa This expertise has been gained using different platforms in commerce from the Koelis Urostation to the most recent Koelis Trinity and the investigators have reported the outcomes of these fusion biopsies on a multicentric series of more than 2000 patients the largest series of fusion biopsies ever published in the literature The natural step forward would be the implementation of the Koelis bioptic platform with the possibility of delivering a focal treatment to the foci of PCa which can be achieved with TATO3 microwave ablation system minimizing side effects while maintaining cancer control
FT is based on the treatment of a part of the prostate containing the index lesion Over 90 of PCa are multifocal and unilateral disease is estimated to be present in only 20-40 of patients Despite the multifocal nature of PCa many affected men have just a single substantial lesion which is called index lesion Ohori et al determined that up to 80 of PCa volume arises through the index lesion Clinically vast evidence indicates that the index lesion features predict the behavior of the disease Indeed risk stratification of the index lesion predicts PCa outcomes irrespectively from the presence of unilateral or bilateral disease and most metastatic PCa arise from the cell clone of the index lesion FT relies on the concept that residual PCa in the untreated area does not compromise long-term disease control given that it falls into the criteria of active surveillance The success of focal therapy strongly depends on the ability to detect the foci of PCa through multiparametric magnetic resonance imaging mpMRI which has gained a paramount role in PCa diagnosis Clinically significant prostatic lesions have features detectable at mpMRI and can be targeted with fusion biopsies which combine the data coming from mpMRI and transrectal ultrasound TRUS imaging Data from PROMIS trial demonstrated MRI sensitivity of 93 for clinically significant cancer and a meta-analysis by Moldovan et al showed a negative predictive value of mpMRI of 881 A European consensus meeting suggested that mpMRI in combination of a systematic sampling achieves a negative predictive value of 90-95 Bearing in mind the limitations of the mpMRI however to-date systematic biopsies are mandatory to ensure the most accurate sampling possible and any FT performed should consider a reasonable security margin
For a successful treatment patient selection is essential Currently the ideal candidates for FT should be patients harboring intermediate-risk PCa with favorable features and a limited component of Gleason score pattern 4 A 2015 consensus meeting stated that providing FT to patients with low-risk prostate cancer would represent overtreatment in men suitable for active surveillance Furthermore candidates for FT must have a life expectancy of more than 5 years and a WHO performance status of 0 or 1 In the last years FT has solidly evolved from low-risk to intermediate-risk disease since the first FT trials more than 2700 patients have been treated and this approach is now at the level of exploration of indications quality control measures and reproducibility in larger trials In 2017 a randomized controlled trial RCT has shown the potential benefits of FT versus active surveillance in low-risk PCa in terms of cancer progression secondary treatments and negative biopsies at 2-yrs follow-up In intermediate-risk PCa another RCT of partial prostate ablation versus RP has completed the feasibility phase the main study is set up with the goal to prove the benefit of FT versus RP in terms of PCa mortality In line with the recommendations of the 2015 consensus meeting the investigators believe that suitable candidates for FT are those with a single small focus of Gleason score 7 34 PCa with possible limited adjunctive presence of clinically insignificant foci of Gleason score 6 33 invisible to mpMRI When speaking of FT for PCa several energy modalities have been developed including high-frequency ultrasound HIFU cryotherapy laser interstitial thermotherapy photodynamic therapy irreversible electroporation brachytherapy and radiofrequency ablation To date studies were able to prove the feasibility low morbidity profile and satisfying short- and medium-term oncologic results of FT mainly based on imaging and rebiopsy Nevertheless according to the last European Association of Urology EAU guidelines FT is still considered experimental to be offered within a clinical trial Recently among energy modalities has emerged also 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
Since the 1980s microwaves have been widely used for the treatment of Benign Prostatic Hyperplasia BPH Low intensity energy is applied to the entire organ to reduce the volume of the gland Several studies have shown the safety of microwaves propagation through the prostate with transurethral transperineal and transrectal accesses while variable results have been achieved in terms of prostate volume reduction
The treatment of PCa by microwaves requires the use of higher energy as compared to BPH treatment in order to irreversibly denature tumor cells A phase III clinical has been led since 1998 to investigate the safety and efficacy of transperineal microwave therapy for recurrent PCa following external beam radiation therapy A preliminary result on 25 patients has shown a very low complication rate following the treatment and good oncological results Six months after the treatment 64 of the biopsy result were negative On the last update of 2004 with 41 patients enrolled no serious complications were observed as a result of the procedure and although mild continence problems were encountered these were generally temporary
TATO3 VLL microwave ablation system represents the last evolution in the field of microwave treatment for PCa Following dry lab testing it has been experimented in the animal setting on dogs More recently it has been used at Hôpital Cochin Paris in the setting of clinical study where preliminary results on 10 patients with low risk PCa showed an excellent safety profile of targeted focal microwave treatment for the ablation of index tumor Final results are awaited this summer Another study is ongoing in at Erasme Hospital Brussels treating patients already scheduled for radical prostatectomy with the aim of examining the extension of the treated area and confirming the absence of cancerous cells To-date the treatment is well tolerated and efficacious
Since 2015 the investigators have acquired a significant expertise in the field of prostate fusion biopsies achieving outstanding cancer detection rates and improving the risk stratification of newly diagnosed PCa This expertise has been gained using different platforms in commerce from the Koelis Urostation to the most recent Koelis Trinity and the investigators have reported the outcomes of these fusion biopsies on a multicentric series of more than 2000 patients the largest series of fusion biopsies ever published in the literature The natural step forward would be the implementation of the Koelis bioptic platform with the possibility of delivering a focal treatment to the foci of PCa which can be achieved with TATO3 microwave ablation system minimizing side effects while maintaining cancer control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None