Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer

  • Recruiting
  • Treatment
  • Interventional
  • Device
  • Northwell Health
  • 45 Years -


Study Purpose

The purpose of this research study is to determine the safety and feasibility of using the UroNav software and DynaCAD software for planning and treating prostate cancer as an add on to the already approved workflow of using ultrasound only during the cryoablation of the prostate. The software application may aid doctors in locating a prior biopsy proven cancer location from the UroNav biopsy that patients previously had and then use that information to guide the treatment.

Intervention

Device : Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance


Eligibility Requirements

info icon Patients must have documented histological or cytological evidence of tumor(s) of the prostate.

info icon Patients must be ≥ 45 years of age.

info icon Patients must be able to read, understand and sign an informed consent.

info icon Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging.

info icon Prostate cancer is diagnosed by MR image guided biopsies.

info icon Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy.

info icon A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy.

info icon If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex).

info icon Prior mpMRI results dated within 120 days prior to ablation.

info icon No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T1 and PSA \> 20 or T2 and PSA \> 10

info icon PSA \< 15 ng/ml or PSA density \< 0.15 ng/ml2 in patients with a PSA \> 15 ng/ml.

info icon ASA status \> 3

info icon Very Low Risk Prostate Cancer based on Epstein's Criteria having a tumor \<0.2 cc (AUA Guidelines 2017 pg. 9)

info icon GG1, PSA \< 10 ng/ml, no more than two positive cores and no core \> 50% involvement.

info icon Contraindications to MRI 3. 1 Claustrophobia 3. 2 Implanted ferromagnetic materials or foreign objects 3. 3 Known intolerance to the MRI or US contrast agents. 3. 4 Severely abnormal coagulation (INR\>1.5

info icon Patients with unstable cardiac status including: 4. 1 Unstable angina pectoris on medication 4. 2 Patients with documented myocardial infarction within 40 days prior to enrolment 4. 3 Congestive heart failure NYHA class IV 4. 4 Patients with unstable arrhythmia status, already on anti-arrhythmic drug

info icon Severe hypertension (diastolic BP \> 100 on medication)

info icon Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

info icon History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.

info icon Patient under medications that can affect PSA for the last 3 months prior to UroNAV Ablation system aided cryo-ablation treatment (Androgen Deprivation Treatment)

info icon Patients with lesions of Gleason 7 or greater outside the planned treatment area.

info icon Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.)

info icon Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe US probe insertion (e.g., fistula, stenosis, fibrosis, inflammatory bowel disease, etc).

info icon Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia

info icon Evidence for lymph node involvement of cancer

info icon Bladder cancer

info icon Urethral stricture/bladder neck contracture

info icon Patients with incontinence demonstrated by use of more than 1 pad/day. .

info icon Active UTI

info icon Prostatitis NIH categories I, II and III.

info icon Compromised renal function

info icon Interest in future fertility

info icon Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment.

Recruiting status

Recruiting

Estimated enrollment

200

 
Study start date

Nov 25, 2020

Study end date

Oct 30, 2025

Last updated

Mar 23, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Device

Study phase

NA

Allocation

Na

 

Sponsor:

Northwell Health

Collaborator:

Philips Healthcare

Investigator:

Ardeshir Rastinehad, DO

NCT04656678

Clinic Location Investigator Distance RECRUITING STATUS Contact