Low-Risk Prostate Cancer
Conditions
Keywords
cancer, prostate, PSA, biopsies, microwave trans rectal focal treatment
Brief summary
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.
Detailed description
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).
Interventions
DEVICEMicrowave trans rectal focal treatment
Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
Sponsors
Unité de Recherche Clinique Necker Cochin, Fr
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged from 45 to 76 years old ; * Life expectancy above 10 years ; * Diagnosis of prostate cancer confirmed on prostate biopsies ; * Low risk of progression, defined with D'Amico criteria : * T1c or T2a stage * Maximum Gleason score of 3+4, including targeted biopsies corresponding to less than 50% grade 4 for the tumor * Prostate Specific Antigen \<15 ng/mL * Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ; * Patient accepting to be followed after the procedure using active surveillance protocol standards ; * Patient affiliated to national health care insurance ; * Free consent, informed and written, dated and signed by the patient and the investigator before enrollment.
Exclusion criteria
* Medical past history of prostatic surgery ; * Medical past history of radiotherapy or pelvic trauma ; * Medical past history of acute or chronic prostatitis * severe BPH-related urinary tract symptoms defined as an IPSS \>18 ; * Extra-capsular extension or seminal vesicle invasion on prostate MRI. * Tumor involvement \> 3 mm on systematic biopsies outside the tumor volume detected on MRI. * Tumor largest axis \> 20 mm on prostate MRI ; * Distance of less than 5 mm between the tumor and the rectum * Patient unable to understand the course of the study * History of allergy or non-tolerance to gadolinium salts used in MRI * Patient with a contraindication to performing an MRI * Person placed under safeguard of justice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete necrosis of the index tumor on prostate MRI | 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Margins of necrosis around the index tumor on prostate MRI | 7 days | — |
| Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire | 7 days | to assess sexual tolerance |
| Urinary symptoms using IPSS | 7 days | to assess urinary tolerance |
| Number of cancer on targeted biopsies within the treated volume | 6 months | to assess oncological efficacy |
Countries
France
Outcome results
None listed