Cryo-ablation for Prostate Cancer

(Focal Therapy Trial)

Recruiting at 2 trial locations

Overseen By Cynthia Knauer, RN

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Northwell Health

Must not be taking: Anti-arrhythmics, Androgen deprivation

Disqualifiers: Severe hypertension, Cardiac issues, Bladder cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 25

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does exclude patients who have been on medications affecting PSA levels in the last 3 months. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Cryo-ablation for Prostate Cancer?

Research shows that cryoablation, a treatment that freezes cancer cells, is effective in controlling localized prostate cancer, especially in low-volume cases, with minimal side effects. Studies have reported promising results, with a high percentage of tumor ablation and minimal complications, making it a viable alternative to surgery or radiation for certain patients. ^{1 2 3 4 5}

How does the Cryo-ablation treatment for prostate cancer differ from other treatments?

Cryo-ablation for prostate cancer is unique because it uses advanced imaging technology, like MRI/ultrasound fusion, to precisely target and freeze cancerous tissue, minimizing damage to surrounding healthy tissue. This approach allows for a focused treatment of localized prostate cancer, offering an alternative to more invasive surgeries or radiation therapies. ^{1 2 3 6 7}

Research Team

Ardeshir Rastinehad, DO

Principal Investigator

Northwell Health

Eligibility Criteria

Men over 45 with intermediate-risk prostate cancer, confirmed by MRI-guided biopsies, Gleason Score ≤7, and no more than two lesions. They must understand the study and consent to it. Excluded are those with severe health issues, metastatic disease, rectal or spinal problems that affect treatment safety, very low risk cancer based on specific criteria, contraindications to MRI or certain medications affecting PSA levels.

Inclusion Criteria

Prior mpMRI results dated within 120 days prior to ablation

My PSA level is below 15 ng/ml or my PSA density is below 0.15 if my PSA is above 15.

My prostate cancer has a low Gleason score and minimal positive biopsy results.

Exclusion Criteria

My prostate cancer is classified as very low risk.

My blood pressure is very high even with medication.

I use more than one pad a day due to incontinence.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo UroNAV Ablation system aided cryo-ablation treatment for prostate cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of tumor control and quality of life

24 months

Regular visits (in-person and virtual) over 24 months

Treatment Details

Interventions

• Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

Trial Overview The trial is testing the safety and effectiveness of using UroNav software combined with DynaCAD for planning cryo-ablation treatments in prostate cancer patients. This technology aims to improve upon ultrasound-only methods by better locating tumors identified in previous biopsies for targeted treatment.

Participant Groups

Group I: DynaCAD / UroNAV Experimental Treatment 1 Intervention

This is a single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument. DynaCAD 5.0 is an image analysis and planning system that will provide off station, pre planning and review of interventional study data. It interfaces with the Uronav 4.0 fusion guidance system.

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cryoablation for:

• Prostate cancer

Approved in European Union as Cryoablation for:

• Prostate cancer
• Kidney cancer
• Liver cancer

Approved in Canada as Cryoablation for:

• Prostate cancer
• Kidney cancer

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Philips Healthcare

Industry Sponsor

Trials

127

Recruited

200,000+

Roy Jakobs

Philips Healthcare

Chief Executive Officer since 2022

Master's in Business Administration from Radboud University Nijmegen and Università degli Studi di Bologna

Dr. Roy Jakobs

Philips Healthcare

Chief Medical Officer

MD from McGill University

Findings from Research

In a study involving three patients with localized prostate cancer, MRI/ultrasound fusion technology was successfully used for focal treatments, including nanoparticle ablation and cryoablation, achieving 100% tumor ablation in all cases.

The use of the DynaCAD 5.0 system for 3D segmentation of tumors and surrounding structures improved preoperative planning, enhancing the precision of needle placement for ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Automated Three-Dimensional Surgical Planning Tool and Magnetic Resonance Imaging/Ultrasound Fusion Technology to Perform Nanoparticle Ablation and Cryoablation of the Prostate for Focal Therapy. Jue, JS., Coons, S., Hautvast, G., et al.[2022]

Transrectal ultrasound-guided percutaneous transperineal prostate cryoablation is a minimally invasive outpatient procedure that effectively treats localized prostate cancer, showing promising results with an 81% success rate in controlling the disease and minimal morbidity over a follow-up period of 5 years.

While cryoablation is effective, especially for low-volume cancers, the complication rates, particularly for salvage procedures after radiation therapy, can be higher, indicating the need for careful patient selection and consideration of treatment history.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cryoablation: update 1998. Schmidt, JD., Doyle, J., Larison, S.[2022]

In a study of 15 patients with locally recurrent prostate cancer after radical retropubic prostatectomy, 40% experienced sustained declines in PSA levels following interstitial transperineal cryoablation, indicating potential effectiveness of this treatment.

The success of cryoablation was associated with lower pre-treatment Gleason scores and smaller lesion sizes, suggesting that patients with more favorable cancer characteristics may benefit more from this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer local recurrence after radical retropubic prostatectomy with 17-gauge interstitial transperineal cryoablation: initial experience. Siddiqui, SA., Mynderse, LA., Zincke, H., et al.[2007]

Cryoablation using the Cryocare System was successfully performed on 10 Brazilian patients with localized prostate cancer, showing promising short-term results with no biochemical relapse after a mean follow-up of 13 months.

While 50% of patients experienced erectile dysfunction post-treatment, all maintained urinary continence, and those with erectile issues responded well to rehabilitation treatments, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial brazilian experience in the treatment of localized prostate cancer using a new generation cryotechnology: feasibility study. Kim, FJ., Cerqueira, MA., Almeida, JC., et al.[2019]

The use of a 3-dimensional transrectal ultrasound imaging system during cryoablation for prostate cancer in 52 patients improved visibility for probe placement and intraoperative monitoring, leading to more precise treatment.

Early postoperative results, including histological and biochemical outcomes, showed complication rates comparable to other contemporary treatments, suggesting that this imaging technique is a promising enhancement for the cryoablation procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional transrectal ultrasound guided cryoablation for localized prostate cancer in nonsurgical candidates: a feasibility study and report of early results. Chin, JL., Downey, DB., Mulligan, M., et al.[2016]

In a study of 50 men with localized prostate cancer, percutaneous perineal cryoablation resulted in a 90% rate of achieving low prostate-specific antigen (PSA) levels (<0.5 ng/mL) at the last follow-up, indicating effective treatment.

The procedure demonstrated a 100% overall survival rate, suggesting that cryoablation is a safe and feasible option for patients with organ-confined prostate cancer, although further research is needed to assess long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term cancer control after primary cryosurgical ablation for clinically localized prostate cancer using third-generation cryotechnology. Polascik, TJ., Nosnik, I., Mayes, JM., et al.[2007]

Percutaneous transperineal cryoablation is an emerging treatment for prostate cancer, utilizing advanced imaging and cryosurgical technology to improve patient outcomes.

This technique is suitable for various patients, particularly for primary treatment of localized prostate cancer, as salvage therapy after other treatments fail, and for alleviating local symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryoablation for carcinoma of the prostate. Patel, BG., Parsons, CL., Bidair, M., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Novel Automated Three-Dimensional Surgical Planning Tool and Magnetic Resonance Imaging/Ultrasound Fusion Technology to Perform Nanoparticle Ablation and Cryoablation of the Prostate for Focal Therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prostate cryoablation: update 1998. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of prostate cancer local recurrence after radical retropubic prostatectomy with 17-gauge interstitial transperineal cryoablation: initial experience. [2007]

4. Brazil pubmed.ncbi.nlm.nih.gov

Initial brazilian experience in the treatment of localized prostate cancer using a new generation cryotechnology: feasibility study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Three-dimensional transrectal ultrasound guided cryoablation for localized prostate cancer in nonsurgical candidates: a feasibility study and report of early results. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Short-term cancer control after primary cryosurgical ablation for clinically localized prostate cancer using third-generation cryotechnology. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Cryoablation for carcinoma of the prostate. [2016]