Micro-wave Ablation Under Organ-based Tracking in Patients With Prostate Cancer - FOSTINE

Focal Treatment for Prostate Cancer Clinical Trial

— FOSTINE  

Official title:

Etude de faisabilité de de tolérance d'un Traitement Focal Transrectal Par Micro-ondes de la Tumeur Index Des Patients Ayant un Cancer de la Prostate - FOSTINE 1b

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04831905
• Other study ID #: FOSTINE
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2021
• Source: Jules Bordet Institute
• Contact: Alexandre Peltier, MD
• Phone: +3225413171
• Email: alexandre.peltier[@]bordet.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the advent of multiparametric MRI (mpMRI), the concept of focal therapy continues to develop as a compromise between active surveillance and radical tratment. However, it must be combined with the most stringent quality control measures, such as exceptional Imaging, to allow close management of the index tumor. the choice of the energy is also crucial. Several have been tested such as HIFU, electroporation or cryotherapy. A new therapeutic alternative currently Under investigation resides in the use of microwaves delivered through a thin needle inserted precisely into the index lesion according to the same procedure as targeted biopsy under image fusion to induce coagulation necrosis and lead to the tumor destruction. Through an ablate, performed transrectally under real-time MRI/TRUS image registration and 3D mapping, in patients with localized prostate cancer (PCa).

Description:

Patients with a detectable index lesion on mpMRI, PSA level <20 ng/mL and wishing to undergo a prostatectomy due to significant PCa on biopsy are elibible for this study approved by the Ethics Committee. Targeted biopsies of the index lesion are performed by using an ultrasound-MRI image fusion system with Organ based Tracking (OBT)-registration (Trinity*, KOELIS, France) to provide quality control. Targeted cores are analyzed intraoperatively with an extemporaneoux analyses. If positive, a targeted focal microwave ablation is achieved during the same session by a single 18G needle inserted transrectally Under sedation. Predictive ablation charts obtained with the 2.45 GHZ frequency microwave generator (TATO, Biomedical Srl, Italy) through ex vivo experiments were used to choose the duration and power of the treatment. Treated patients are followed-up for 4 to 6 weeks and the planned radical prostatectomy is performed. All treated patients complete uroflowmetry test and questionnaires (IPSS, IPSS-QQL, IIEF-5, and MSHW-EJD-SF) befor, at 7 days and 1 month after the procedure. A mpMRI of the treated prostate is performed at 7 days after the ablation to identify the devascularized area, but also to verify that no organ at risk is affected by the microweve treatment. After radical prostatectomy, whole-mount histology serves to define the ablation boundaries and dimension in the prostate. It also allows to determine the impact of the use of microwaves on cancerous tissue. A total of 10 patients will be enrolled.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 76 Years

Eligibility

Inclusion Criteria:

• Patients with detectable index lesion on mpMRI, PSA level <20 ng/mL and wishing to undergo a prostatectomy due to significant PCA on biopsy.
• Life expectancy up to 10 years or plus.

Exclusion Criteria:

• Past history of prostate surgery or pelvic radiotherapy, prostatitis, extra-capsular extension on MRI or index lesion above 25 mm, distance between rectum and index lesion less than 5 mm.

Related Conditions & MeSH terms

• Focal Treatment for Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Micro-wave ablation
Micro-wave ablation

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Bruxelles

Sponsors (2)

Lead Sponsor	Collaborator
Jules Bordet Institute	Koelis

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Micro-wave ablation area	Tolerance and faisability of transerectal micro wave ablation of index lesion in prostate cancer.	6 weeks
Secondary	Micro-wave ablation area	MRI to identify the devascularized area at one week and ablation boundaries and dimensions in the prostate specimen after prostatectomy at one month.	6 weeks

External Links

•   Fusion device