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

Inclusion Criteria:

1. Patients must have documented histological or cytological evidence of tumor(s) of theprostate.
2. Patients must be ≥ 45 years of age.
3. Patients must be able to read, understand and sign an informed consent.
4. Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MRimaging.
5. Prostate cancer is diagnosed by MR image guided biopsies.
6. Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guidedprostate biopsy.
7. A non MRI visible cancer detected via systematic standard biopsy will not beconsidered an exclusion condition provided the non-MRI visible cancer is singularlylocated in the contralateral hemisphere of the prostate; is Gleason 6 cancer; andcomprises no more than 6mm linear extent of cancer in a single core on standardbiopsy.
8. If any standard biopsy cores are positive on the same hemisphere of the prostategland, they must be confirmed as likely to form a contiguous lesion with the targetlesion detected on MRI and therefore be from the same location in the prostate as MRlesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland,Apex).
9. Prior mpMRI results dated within 120 days prior to ablation.
10. No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated tor/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10
11. PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml.

Exclusion Criteria:

1. ASA status > 3
2. Very Low Risk Prostate Cancer based on Epstein's Criteria having a tumor <0.2 cc (AUAGuidelines 2017 pg. 9) GG1, PSA < 10 ng/ml, no more than two positive cores and no core > 50% involvement.
3. 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)
4. 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 drugs
5. Severe hypertension (diastolic BP > 100 on medication)
6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
7. History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy,Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; anyprior radiation therapy to the pelvis for prostate cancer or any other malignancy.
8. Patient under medications that can affect PSA for the last 3 months prior to UroNAVAblation system aided cryo-ablation treatment (Androgen Deprivation Treatment)
9. Patients with lesions of Gleason 7 or greater outside the planned treatment area.
10. Individuals who are not able or willing to tolerate the required prolonged stationarysupine position during treatment (approximately 3 hrs.)
11. Any rectal pathology, anomaly or previous treatment, which could change acousticproperties of rectal wall or prevent safe US probe insertion (e.g., fistula, stenosis,fibrosis, inflammatory bowel disease, etc).
12. Any spinal pathology which can prevent safe administration of epidural/spinalanesthesia
13. Evidence for lymph node involvement of cancer
14. Bladder cancer
15. Urethral stricture/bladder neck contracture
16. Patients with incontinence demonstrated by use of more than 1 pad/day. .
17. Active UTI
18. Prostatitis NIH categories I, II and III.
19. Compromised renal function
20. Interest in future fertility
21. Current participation in another clinical investigation of a medical device or a drugor has participated in such a study within 30 days prior to study enrollment.