Miami Lakes, Florida 33016


Purpose:

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.


Study summary:

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


Criteria:

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


NCT ID:

NCT02381990


Primary Contact:

Principal Investigator
FERNANDO J BIANCO, MD
UROLOGICAL RESEARCH NETWORK

CIELO D GUERRA, BS
Phone: 305-515-9887
Email: CIELO@BESTUROLOGY.NET


Backup Contact:

Email: LUANDA@BESTUROLOGY.NET
LUANDA SIANO, PA
Phone: 305-822-7227


Location Contact:

Miami Lakes, Florida 33016
United States

CIELO D GUERRA, BS
Phone: 305-515-9887
Email: CIELO@BESTUROLOGY.NET

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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