An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate Cancer

Inclusion criteria:

• English-speaking adult males

• Life expectancy over 10 years as assessed by treating physician

• Prior to enrollment, MRI fusion biopsy of MRI-visible lesion required (as detailedbelow, which includes systematic biopsy cores)

• Single focus GG2 or GG3 (additional GG1 allowed up to 6mm, noting that a singlefocus of disease is defined as an area seen on MRI that may be biopsied multipletimes using targeted biopsies and have systematic core biopsies directly adjacent totargeted cores; all of which being considered as from the same focus)

• Histologically confirmed adenocarcinoma of prostate

• Organ-confined prostate cancer, clinical stage ≤T2bN0M0

• Visible tumor on MRI

• No clear evidence or high suspicion of extraprostatic extension or seminalvesical invasion on MRI

• Biopsy via transperineal or transrectal approach with at least 2 cores of MRIvisible lesions that are PIRADS 2 or higher and 12 core systematic biopsytemplate (exclusion of cores from systematic template that overlap withtargeted cores allowed).

• Additional performance of microultrasound guided biopsy is allowed though notrequired. Please note that every effort will be made to correlatemicroultrasound findings with MRI, in order to determine if positive resultsare from the same MRIvisible focus. This determination will be made by thesurgeon performing the biopsy.

• Note that GGG 1 disease at sites other than ablation zone are allowed providedthese are 6mm or less in size. PSA ≤15 ng/mL, or PSAD <0.15 if PSA >15 ng/mL

• Physician can fully visualize the prostate on transrectal ultrasound on entry biopsy

• Lesion anatomically amenable to cryotherapy treatment based on treating physician'sdiscretion

• Willing and able to read, understand and sign the study specific informed consentdocument

• Willing and agreeable to comply with study protocol requirements, including focalcryotherapy ablation and all follow up visit requirements

• Patients must consent to investigative laboratory protocol (such as, but not limitedto, 2021- 0560)

Exclusion criteria:

• Gleason grade group 4 or 5 disease

• Medical history or concurrent disease, which in the opinion of the investigator,poses the patient at significant peri-operative risk of complication due toanesthesia or the procedure

• Active urinary tract infection

• Any previous treatment for prostate cancer, including radiation therapy, hormonaltreatment, biologic therapy for prostate cancer, or chemotherapy

• Prior TURP or other prostate outlet procedure such as HoLEP, greenlight, microwaveablation, aquablation, UroLift, or simple prostatectomy.

• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease

• Inability to obtain prostate MRI (ex. due to claustrophobia, pacemaker, orprohibitive implants)

• Unwilling to consent to laboratory investigative protocol (such as, but not limitedto, 2021- 0560)