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Fuse Image MRI Guided Prostate Cryotherapy (FIPC)

This study is currently recruiting participants.
Verified March 2015 by Urological Research Network, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02381990
First Posted: March 6, 2015
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Urological Research Network, LLC
  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.

Condition Intervention
Neoplasms Prostate Cancer of the Prostate Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Office Based Fuse Image MRI Guided Prostate Cryotherapy: Outcomes Registry

Resource links provided by NLM:


Further study details as provided by Urological Research Network, LLC:

Primary Outcome Measures:
  • Oncological Control [ Time Frame: 1 Year ]
    Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy


Secondary Outcome Measures:
  • Oncological Control [ Time Frame: 1 Year ]
    Lack of prostate cancer presence in the gland after MRI/US FUSION Biopsy

  • Oncological Control [ Time Frame: Yearly, up to 10 years ]
    Lack of prostate cancer presence in gland measured by MP-MRI

  • 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

  • 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

  • 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


Other Outcome Measures:
  • Secondary Treatment Requirement [ Time Frame: Yearly, up to 10 years ]
    Type of treatments required after initial intervention over time


Estimated Enrollment: 5000
Study Start Date: July 2013
Estimated Study Completion Date: June 2023
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY
    Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic "cryoprobes/devices" are employed to freeze and all "circuled or noted" cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins
    Other Name: Intervention of Interest: Prostate Cryoablation
Detailed Description:

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
As written in Initial Section
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381990


Contacts
Contact: CIELO D GUERRA, BS 305-515-9887 CIELO@BESTUROLOGY.NET
Contact: LUANDA SIANO, PA 305-822-7227 LUANDA@BESTUROLOGY.NET

Locations
United States, Florida
Urological Research Network Recruiting
Miami Lakes, Florida, United States, 33016
Contact: CIELO D GUERRA, BS    305-515-9887    CIELO@BESTUROLOGY.NET   
Principal Investigator: FERNANDO J BIANCO, MD         
Sub-Investigator: EDWARD L GHEILER, MD         
Sub-Investigator: ARIEL M KAUFMAN, MD         
Sponsors and Collaborators
Urological Research Network, LLC
Investigators
Principal Investigator: FERNANDO J BIANCO, MD UROLOGICAL RESEARCH NETWORK
  More Information

Publications:

Responsible Party: Urological Research Network, LLC
ClinicalTrials.gov Identifier: NCT02381990     History of Changes
Other Study ID Numbers: URN-13-1010
First Submitted: January 12, 2015
First Posted: March 6, 2015
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by Urological Research Network, LLC:
Prostate
Cancer
PSA
FUSION
Ultrasound
MRI
Cryotherapy
Outcomes
Recurrence
QOL, Quality of Life
Urinary function
Sexual Function

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases