FIPC: MRI/Ultrasound Fusion Guided Prostate Cryotherapy

Sponsor

Urological Research Network, LLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT02381990

Collaborator

(none)

5,000

Enrollment

Location

262

Anticipated Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasms Prostate Cancer of the Prostate	Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

Detailed 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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

Actual Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Jun 1, 2035

Outcome Measures

Primary Outcome Measures

Oncological Control [1 Year]
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy

Secondary Outcome Measures

Oncological Control [1 Year]
Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy
Oncological Control [Yearly, up to 10 years]
Lack of prostate cancer presence in gland measured by MP-MRI
Urinary Functional Outcomes [Every 3 months up to 24 months]
Evaluation of urinary function outcomes when compared to baseline using expanded prostate composite index and AUA symptoms scores. Urinary function also by objective measurements - uroflow and post void residuals
Perioperative Outcomes [30 days]
Procedure tolerance, need for hospital admission or ER consultation, incidence of urinary tract infection, urinary retention, any significant side effect that may occur and perioperative survivel
Sexual Functional Outcomes [Every 3 months up to 24 months]
Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires

Other Outcome Measures

Secondary Treatment Requirement [Yearly, up to 10 years]
Type of treatments required after initial intervention over time

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

Male

Accepts 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