Phase II Trial of Focal Cryotherapy for Prostate Cancer

Study Overview
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Brief Summary
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The current standard of care treatment for prostate cancer confined to the prostate is surgical removal or irradiation of the entire prostate gland. This is effective at curing cancer but result in damage to critical adjacent structures such as the urinary sphincter muscle and erectile nerves resulting in impaired urinary continence and erectile dysfunction. The concept of focal therapy is to treat just the dangerous focus of cancer in the prostate while monitoring the rest of the gland, thus avoiding impairment of urinary continence and erectile function. We aim to evaluate the degree of preservation of continence and erectile function and early oncological outcomes in patients undergoing focal therapy of the prostate using cold energy or cryo- ablation. In this study, we seek to evaluate patient reported outcomes in urinary, sexual, bowel and general health areas at fixed time points after focal cryo-ablation in selected patients with low-volume, localized cancer. The primary goal of this study is to demonstrate whether there is a deterioration of scores in these health areas over 1 year of follow-up. The secondary goal is to measure cancer control at 1 year re-biopsy. Further goals include longer follow-up to monitor cancer progression rates and impact on patient survival.

Official Title
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Phase II Trial of Focal Cryotherapy for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Focal Cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: PSA (prostate specific antigen) ≤ 20 Biopsy Gleason score ≤ 4+4 mpMRI shows no gross extracapsular extension mpMRI shows index lesion volume < 3 ml ≤ 2 biopsy confirmed lesions on mpMRI Exclusion criteria: American Society of Anesthesiologist score >3 Very high grade cancer (Gleason score > 4+4) >2 index lesions Multifocal cancer (any other Gleason >3+3 present and/or Gleason 3+3 at > 3 biopsy cores at another site) - Not eligible for mpMRI Not fit for robotic transperineal saturation biopsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focal Cryotherapy<br>Focal Cryotherapy using 2 freeze-thaw cycles | Device: Focal Cryotherapy<br>* Ablation of the cancer focus within the prostate using cryotherapy<br>* Other names: Focal Cryoablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in EPIC (Expanded Prostate Composite Index) subdomain score at 1, 3, 6, 12 months compared to baseline |  | 1,3,6 and 12 months | 
| Number of Participants with Treatment-Related Adverse Events assessed by the Clavien-Dindo Scale |  | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infield (focally treated area) and Outfield (untreated area) positive biopsy rate at 12 months |  | at 12 months |