Focal Ablation With Focal Cryotherapy or HIFU for the Treatment of Men With Localized Prostate Cancer

Study Overview
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Brief Summary
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This clinical trial evaluates the effectiveness of focal ablation with either focal cryotherapy or high intensity frequency ultrasound for the treatment of men with localized prostate cancer. Focal cryotherapy kills tumor cells by freezing them. High intensity frequency ultrasound uses highly focused ultrasound waves to produce heat and destroy tumor cells.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine the efficacy of focal therapy for treatment of prostate cancer. SECONDARY OBJECTIVES: I. Patient reported urinary, sexual function and quality of life (QOL) at 1 year. II. To assess safety. OUTLINE: Patients undergo focal cryotherapy or high intensity focused ultrasound on study. After completion of study treatment, patients are followed up at 7-14 days and periodically for up to 3 years.

Official Title
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A Pragmatic Phase 2 Study of Focal Ablation (Focal Cryotherapy or High Intensity Frequency Ultrasound) in Men With Clinically Localized Prostate Cancer

Conditions
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Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8

Intervention / Treatment
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* Procedure: Cryosurgery
* Procedure: High-Intensity Focused Ultrasound Ablation
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willingness to sign an informed consent form Clinically localized grade group 1, 2, or 3 prostate cancer and unilateral magnetic resonance imaging (MRI) visible lesion(s). Up to 3 lesions will be allowed for focal treatment Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥ 70%) Patients ≥ 18 years of age at time of consent Life expectancy ≥ 5 years Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study Exclusion Criteria: Nodal or distant metastases Prior treatment for prostate cancer Anticipated treatment with any cancer intervention, including radiation, hormonal therapy or surgery ≤ 6 months prior to focal therapy in this study Known contraindications to general anesthesia Uncorrectable coagulopathy Significant active cardiac disease within the previous 6 months including: New York Heart Association (NYHA) class 4 congestive heart failure (CHF), unstable angina, or myocardial infarction Any condition that would prohibit the understanding or rendering of informed consent Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on trial

Ages Eligible for Study
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Minimum Age: 18 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: Treatment (cryosurgery, high intensity focused ultrasound)<br>Patients undergo focal cryotherapy or high intensity focused ultrasound on study. | Procedure: Cryosurgery<br>* Undergo focal cryotherapy ablation<br>* Other names: cryosurgical ablation;Procedure: High-Intensity Focused Ultrasound Ablation<br>* Undergo high intensity frequency ultrasound ablation<br>* Other names: High-intensity Focused Ultrasound Therapy;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic outcome on surveillance prostate biopsy | Confidence intervals for the pathologic response rate will be calculated using the Wilson score method. Pathologic response rate will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable logistic regression. | At year 1 and 3 | 
| Proportion of participants who go onto whole gland salvage treatment | Will be estimated using the Kaplan-Meier method. | At 3 years | 
| Salvage whole gland treatment free survival | Will be analyzed by baseline clinical and molecular characteristics using univariable and multivariable Cox proportional hazards models. | At 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary function | Scores from Expanded Prostate Cancer Index Composite (EPIC-26) prostate cancer questionnaire will be used to assess urinary function. | At 1 year | 
| Sexual function | Scores from EPIC-26 prostate cancer questionnaire will be used to assess sexual function. | At 1 year | 
| Quality of life | Scores from EPIC-26 prostate cancer questionnaire will be used to assess quality of life. | At 1 year | 
| Adverse events | Number of participants experiencing treatment-related AEs, classified by severity and grade. | Up to end of treatment visit, approximately 7-14 days after treatment |