Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With … (NCT04582656) | Clinical Trial Compass
CompletedNot Applicable
Efficacy Assessment of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
Belgium, France76 participantsStarted 2021-02-11
Plain-language summary
Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.
Who can participate
Age range45 Years – 80 Years
SexMALE
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Inclusion Criteria:
* Patient aged from 45 to 80 years old
* Life expectancy \>10 years at the inclusion time
* Patient diagnosed with an intermediate-risk prostate cancer, defined by:
* A T1c or T2a clinical stage
* A unique cancer focus of Gleason (3+4) (Grade Group 2). In addition to the index lesion intended for treatment, the presence of additional microfoci \< 10mm on mpMRI, for which biopsies present no evidence of cancer or a Gleason score of 3+3, is accepted
* A PSA level \<20 ng/mL
* Cancer focus identified on a multiparametric MRI of the prostate no more than 3 months before inclusion
* Confirmation of the suspicion of cancer identified on the MRI with transrectal or transperineal targeted and systematic biopsies performed with the KOELIS TRINITY system (no more than 3 months before inclusion)
* Patient suitable for IV sedation or general anesthesia and focal microwave ablation
* No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
* Known coagulopathy or bleeding disorders are controlled
* Free, informed and written consent, dated and signed before the enrollment and before any exam required by the trial
* Patient affiliated to social security regimen or beneficiary of such regimen for local regions
Exclusion Criteria:
* Past medical history of prostate surgery
* Past medical history of radiotherapy or pelvic trauma
* Past medical history of acute prostatitis
* Presently t…
What they're measuring
1
The proportion of patients with no evidence of cancer on targeted biopsy