Micro-wave Ablation Under Organ-based Tracking in Patients With Prostate Cancer - FOSTINE
FOSTINE
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
1 other identifier
interventional
10
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedApril 5, 2021
March 1, 2021
1 month
April 1, 2021
April 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Micro-wave ablation area
Tolerance and faisability of transerectal micro wave ablation of index lesion in prostate cancer.
6 weeks
Secondary Outcomes (1)
Micro-wave ablation area
6 weeks
Study Arms (1)
Pilote study
EXPERIMENTALMicro-wave ablation of index lesion identified on MRi on prostate cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jules Bordet Institutelead
- Koeliscollaborator
Study Sites (1)
Institut Jules Bordet
Brussels, 1000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 5, 2021
Study Start
March 1, 2021
Primary Completion
April 1, 2021
Study Completion
May 1, 2021
Last Updated
April 5, 2021
Record last verified: 2021-03