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

Launched by NORTHWELL HEALTH · Dec 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat prostate cancer using advanced software called UroNav and DynaCAD. The goal is to see if these tools can help doctors better locate and treat cancer in the prostate when using a method called cryoablation, which freezes the cancer cells. This study is open to men aged 45 and older who have been diagnosed with specific types of prostate cancer that can be seen on MRI scans. Participants must have had a recent MRI-guided biopsy confirming their cancer and meet other health criteria.

If you decide to participate, you'll have the opportunity to receive this cutting-edge treatment while being closely monitored for safety and effectiveness. It’s important to know that there are specific health conditions that could exclude someone from participating, such as certain heart problems or prior treatments for prostate cancer. Overall, the trial aims to improve prostate cancer treatment by using innovative technology to help doctors make more informed decisions about care.

Gender

MALE

Eligibility criteria

• 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.