The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.
In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment. The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
Assistance Publique - Hôpitaux de Paris
Paris, Paris, France
Complete necrosis of the index tumor on prostate MRI
Time frame: 7 days
Margins of necrosis around the index tumor on prostate MRI
Time frame: 7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Time frame: 7 days
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Time frame: 1 month
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Time frame: 3 months
Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire
to assess sexual tolerance
Time frame: 6 months
Urinary symptoms using IPSS
to assess urinary tolerance
Time frame: 7 days
Urinary symptoms using IPSS
to assess urinary tolerance
Time frame: 1 month
Urinary symptoms using IPSS
to assess urinary tolerance
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Urinary symptoms using IPSS
to assess urinary tolerance
Time frame: 6 months
Number of cancer on targeted biopsies within the treated volume
to assess oncological efficacy
Time frame: 6 months