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.
This is a single-center, prospective, single arm study to evaluate feasibility of UroNAV
Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined
prostate cancer. All subjects will be treated and then followed up clinically for up to 24
months to evaluate any procedure or device related adverse events as well as to assess
efficacy endpoints of the study. Additional data related to quality of life of treated
subjects will also be collected
Inclusion Criteria:
1. Patients must have documented histological or cytological evidence of tumor(s) of the
prostate.
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 MR
imaging.
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 guided
prostate biopsy.
7. 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.
8. 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).
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 to
r/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 (AUA
Guidelines 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; any
prior 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 UroNAV
Ablation 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 stationary
supine position during treatment (approximately 3 hrs.)
11. 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).
12. Any spinal pathology which can prevent safe administration of epidural/spinal
anesthesia
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 drug
or has participated in such a study within 30 days prior to study enrollment.