MRI/Ultrasound Fusion Guided Prostate Cryotherapy (FIPC)

January 24, 2023 updated by: Urological Research Network, LLC

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Urological Research Network
        • Contact:
        • Principal Investigator:
          • FERNANDO J BIANCO, MD
        • Sub-Investigator:
          • EDWARD L GHEILER, MD
        • Sub-Investigator:
          • ARIEL M KAUFMAN, MD
        • Sub-Investigator:
          • EUSEBIO J LUNA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

As written in Initial Section

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological Control
Time Frame: 1 Year
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oncological Control
Time Frame: 1 Year
Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy
1 Year
Oncological Control
Time Frame: Yearly, up to 10 years
Lack of prostate cancer presence in gland measured by MP-MRI
Yearly, up to 10 years
Urinary Functional Outcomes
Time Frame: 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
Every 3 months up to 24 months
Perioperative Outcomes
Time Frame: 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
30 days
Sexual Functional Outcomes
Time Frame: Every 3 months up to 24 months
Evaluation of sexual function outcomes when compared to baseline using Sexual Inventory for men questionnaires
Every 3 months up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Treatment Requirement
Time Frame: Yearly, up to 10 years
Type of treatments required after initial intervention over time
Yearly, up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urological Research Network, LLC

Investigators

  • Principal Investigator: FERNANDO J BIANCO, MD, Urological Research Network
  • Study Director: EUSEBIO LUNA, MD, Urological Research Network
  • Study Director: Isabel H Lopez, MD, Urological Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2033

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URN-13-1010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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