Study of NanoKnife for Ablation of Prostate Cancer in Low and Intermediate Risk Patients
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 20-003218
NCT ID: NCT01972867
Sponsor Protocol Number: ON-NK310
About this study
The purpose of this study is to determine the safety of the NanoKnife treatment in prostate cancer tissue when used in a low and intermediate risk patient population.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Subjects are required to fulfill all the following criteria to be included in the study:
- Has at least a 10 year life expectancy.
- Have histologically confirmed organ-confined prostate cancer - clinical Stage T1 or T2a.
- Have a PSA less than 10 ng/mL.
- Has Gleason score 3+3 or 3+4/4+3.
- Has 10 mm or less of cancer in any biopsy core.
- 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 low to intermediate risk lesion1 in the area of the MR-visible lesion (within 2 Barzell zones).
- An visible lesion on mpMRI, that is accessible to IRE treatment.
- Must sign a written informed consent.
- Understands and accepts the obligation and is logistically able to present for all scheduled follow-up visits.
Subjects will be excluded from participation in the study if they meet any of the following:
- 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 (e.g., 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 prior diagnosis of prostate cancer.
- Have a non-visible tumor on mpMRI.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Publications are currently not available