Focal Treatment for Prostate Cancer Clinical Trial
— FOSTINEOfficial 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
NCT number | NCT04831905 |
Other study ID # | FOSTINE |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | May 1, 2021 |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Jules Bordet Institute | Koelis |
Belgium,
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 |