| TITRE |
(EN) A Pilot Study Evaluating Safety and Efficacy of Transperineal Focal Irreversible Electroporation (IRE) of Anterior Prostate Cancer in Patients With an Intermediate Risk. |
| PROTOCOLE ID |
2021-2815 |
| CLINICAL TRIAL.gov ID |
NCT05512663 |
| TYPE(S) DE CANCER |
Prostate |
| PHASE |
Autres |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
3755 rue de la Côte Ste. Catherine
(514) 340-8222
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Maurice Anidjar
|
| COORDONATEUR(RICE) |
Oleg Loutochin
oloutochin@jgh.mcgill.ca
514-340-8222 poste 21627
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Has at least a 10 year life expectancy
- Have histologically confirmed organ-confined prostate cancer - clinical Stage T1-T2c N0M0
- Have a PSA <=15ng/mL
- Has Gleason <=7 (4+3 or 3+4)
- Has maximum cancer core length >=4mm
- No evidence of extraprostatic extension or seminal vesicle invasion by mpMRI
- Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation
- Transperineal prostate biopsies (template mapping and/or limited targeted) correlating with clinically significant lesion in the area of the MR-visible lesion (within 2 Barzell zones)
- A visible lesion on mpMRI, that is accessible to IRE treatment
- 1Must sign a written informed consent
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits
|
| CRITÈRES D'EXCLUSION |
(EN)
-
Have known hypersensitivity to pancuronium bromide, atricurium or cisatricurium
-
Unfit for anthesthia or have a contraindication for agents listed for paralysis
-
Have an active urinary tract infection (UTI)
-
Have a history of bladder neck contracture
-
Are interested in future fertility
-
Have a history (within 3 years) of inflammatory bowel disease
-
Have a concurrent major debilitating illness
-
Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
-
Have any active implanted electronic device (eg, pacemaker)
-
Are unable to catheterize due to a urethral stricture disease
-
Have had prior or current prostate cancer therapies:
- Biologic therapy for prostate cancer
- Chemotherapy for prostate cancer
- Hormonal therapy for prostate cancer within three months of procedure
- Radiotherapy for prostate cancer
- Surgery for prostate cancer
- Have had prior transurethral prostatectomy (TURP), or urethral stent
- Have had prior major rectal surgery (except hemorrhoids)
- Unfit for pelvic MRI scanning (e.g. severe claustrophobia, permanent cardiac pacemaker, metallic implant etc… likely to contribute significant artefact to images)
- Have a non-visible tumor on mpMRI
|
