Using advanced imaging to guide cryo-ablation for prostate cancer treatment

A Study to Evaluate the Safety and Efficacy of Focal US Guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Locally Confined Low to Intermediate Risk Prostate Cancer

This study is testing if using advanced imaging tools can make cryo-ablation treatment safer and more effective for men with low to intermediate risk prostate cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 45 Years and up
• Sex: Male
• Sponsor: Northwell Health (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Lake Success, New York and 2 other locations)
• Trial ID: NCT04656678 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and feasibility of using UroNav and DynaCAD software to enhance the planning and execution of cryo-ablation for patients with low to intermediate risk prostate cancer. It is a single-center, prospective study where patients will undergo cryo-ablation treatment guided by advanced imaging techniques. Participants will be monitored for up to 24 months to assess any adverse events and the effectiveness of the treatment, along with collecting data on their quality of life post-procedure.

Who should consider this trial

Good fit: Ideal candidates are men aged 45 and older with organ-confined prostate cancer diagnosed via MRI-guided biopsies and a Gleason Score of 7 or lower.

Not a fit: Patients with advanced prostate cancer or those whose cancer is not visible on MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the precision and outcomes of prostate cancer treatment while minimizing side effects.

How similar studies have performed: Other studies have shown promising results using imaging-guided techniques for prostate cancer treatment, suggesting potential success for this approach.

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.

Where this trial is running

Lake Success, New York and 2 other locations

• The Smith Institute for Urology — Lake Success, New York, United States (RECRUITING)
• The Smith Institute for Urology at Lenox Hill — New York, New York, United States (RECRUITING)
• Manhattan Eye, Ear, and Throat Hospital (MEETH) — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Ardeshir Rastinehad, DO — Northwell Health
• Study coordinator: Ardeshir R Rastinehad, DO

Conditions: Prostate Cancer, Prostate Disease, Prostate MRI, Cryoablation, Focal Therapy, Focal Prostate Cancer Therapy