MRI/Ultrasound Fusion Guided Prostate Cryotherapy (FIPC)

Urological Research Network, LLC

Status: Enrolling

Conditions: Neoplasms Prostate; Cancer of the Prostate

Treatments: Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

Study type: Observational

Funder types: Other

Identifiers

NCT02381990

URN-13-1010

Details and patient eligibility

About

Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.

Full description

CLINICAL TRIAL OF OBSERVATION NATURE

PRIMARY OUTCOME

Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival

SECONDARY OUTCOMES

Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care

DATA COLLECTION

• Complete H&P, family history, past medical and surgical history, social history, allergies, and medications
• As of July 2016, voluntary measurement thru Focalyx App for smartphones and tablets
• Imaging Specifics Assessing Prostate, Seminal Vesicles and Urethral Contouring by Multi-parametric-MRI. Dominant lesions and secondary lesions contouring my MP-MRI.
• Procedure specific Co-Registration quality with ultrasound denoting quality
• Specific ablative description and digitalization of critical measures such as: ablation type (ej cryotherapy, equipment used) 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
• 5, 10, 15 Yr CT Scans, PET Scan/Bone Scan

SAFETY MEASURES

• Periodic evaluation of registry to ensure consistency in follow up
• Patient remainders of tests required

Enrollment: 5,000 estimated patients

Sex: Male

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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