| Titre |
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 |
| ClinicalTrials.gov ID |
NCT05512663 |
| Type(s) de cancer |
Prostate |
| Phase |
Autres |
| Type étude |
Clinique |
| Médicament |
Irreversible Electroporation (IRE) |
| Institution |
CIUSSS DU CENTRE-OUEST-DE-L'ILE-DE-MONTREAL
 HOPITAL GENERAL JUIF SIR MORTIMER B.DAVIS
3755 rue de la Côte Ste. Catherine, Montréal, QC, H3T 1E2
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Maurice Anidjar
|
| Coordonnateur(trice) |
Oleg Loutochin
514-340-8222 poste 21627
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
-
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
|
Groupe d'étude en oncologie du Québec