RECRUITING

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

Conditions

Prostate Cancer Prostate Disease Prostate MRI Cryoablation Focal Therapy Focal Prostate Cancer Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-25

Study Completion:2025-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04656678

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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) 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.

Inclusion Criteria

Exclusion 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.

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)
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.

Contacts and Locations

Study Contact

Ardeshir R Rastinehad, DO

CONTACT

212-434-6580

Arastine@northwell.edu

Cynthia Knauer, RN

CONTACT

646-874-4733

cknauer1@northwell.edu

Principal Investigator

Ardeshir Rastinehad, DO

PRINCIPAL_INVESTIGATOR

Northwell Health

Study Locations (Sites)

The Smith Institute for Urology

Lake Success, New York, 11042

United States

The Smith Institute for Urology at Lenox Hill

New York, New York, 10022

United States

Manhattan Eye, Ear, and Throat Hospital (MEETH)

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Northwell Health

Ardeshir Rastinehad, DO, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-25

Study Completion Date2025-10-30

Study Record Updates

Study Start Date2020-11-25

Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

Prostate MRI
Cryoablation
Focal Therapy
Focal Prostate Cancer Therapy
Prostate Cancer

Additional Relevant MeSH Terms

Prostate Cancer
Prostate Disease