Fuse Image MRI Guided Prostate Cryotherapy

CLINICAL TRIAL OF OBSERVATION NATURE

PRIMARY OUTCOME

Cancer control of treated areas 5 years after intervention based on prostate biopsy of
initial treated area

SECONDARY OUTCOMES

Lack of cancer presence or progression 5 years after initial intervention by MP-MRI imaging;
urinary and sexual function changes in quality of life; anxiety related to cancer and cancer
control, number of biopsies required during study period; need of further treatment for
prostate cancer; treatment tolerance to local anesthesia

DATA COLLECTION

- Complete H&P, family history, past medical and surgical history, social history,
allergies, and medications

- Procedure Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by
MP-MRI. Dominant lesions and secondary lesions contouring my MP-MRI. Co-Registration
quality, date of procedure, cryoprobes used, freeze/thaw cycles timing, temperatures at
neurovascular bundles, denonvilliers fascia. Urethral warmer requirements

- Follow up information: 30 day perioperative outcomes (incidence of UTI, urinary
retention, failure of local anesthetic, pain measures). 6 week, 3,6,9,12 month and then
every 6 month measures of PSA, Testosterone levels, Urinary Function and Sexual
Function inventories, Overall anxiety and regret related to diagnosis and treatment

- Uroflow and PVR measurements by 3 to 6 month of treatment

- MP MRI on a yearly basis, for years 2,3,4 after treatment, biopsy driven by new
suspicious MRI findings

- MP MRI triggered by elevation in PSA velocity or PSA level 10% above diagnosis

- Transperineal Fusion Guided Prostate biopsy at 1st year - emphasis on treated areas,
suspicious MRI areas

- Transperineal Fusion Guided Prostate biopsy at 5th year - emphasis on treated areas,
suspicious MRI areas

SAFETY MEASURES

- Periodic evaluation of registry to ensure consistency in follow up

- Patient remainders of tests required

Inclusion Criteria:

- Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with
Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate
lobe

- Men older than 65 years of age with clinical diagnosis of prostate cancer <50%
positive core rate by prostate lobe

- Absence of extra-capsular extension

- Absence of seminal vesicle invasion

- Absence of regional or distant metastatic disease

- Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks
after prostate biopsy

- Treated with Cryotherapy of the prostate

- Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion Criteria:

- Prior treatment of prostate cancer in the form of surgery.

- Performance status greater than 0 based on ECOG criteria

- Mental status impairment