Prostate Cancer Clinical Trial
MRI/Ultrasound Fusion Guided Prostate Cryotherapy
Summary
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
Eligibility 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
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There is 1 Location for this study
Miami Lakes Florida, 33016, United States More Info
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