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MRI/Ultrasound Fusion Guided Prostate Cryotherapy (FIPC)

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ClinicalTrials.gov Identifier: NCT02381990
Recruitment Status : Recruiting
First Posted : March 6, 2015
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Urological Research Network, LLC

Tracking Information
First Submitted Date January 12, 2015
First Posted Date March 6, 2015
Last Update Posted Date October 4, 2021
Actual Study Start Date August 2013
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 24, 2015)
Oncological Control [ Time Frame: 1 Year ]
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy
Original Primary Outcome Measures
 (submitted: March 5, 2015)
Oncological Control [ Time Frame: 1 Year ]
Lack of prostate cancer presence in treated area after FUSION Biopsy
Change History
Current Secondary Outcome Measures
 (submitted: March 24, 2015)
  • 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
Original Secondary Outcome Measures
 (submitted: March 5, 2015)
  • Oncological Control [ Time Frame: 1 Year ]
    Lack of prostate cancer presence in treated area after 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
Current Other Pre-specified Outcome Measures
 (submitted: March 5, 2015)
Secondary Treatment Requirement [ Time Frame: Yearly, up to 10 years ]
Type of treatments required after initial intervention over time
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title MRI/Ultrasound Fusion Guided Prostate Cryotherapy
Official Title Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population As written in Initial Section
Condition
  • Neoplasms Prostate
  • Cancer of the Prostate
Intervention 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
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2015)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2035
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: CIELO D GUERRA, BS 305-515-9887 CIELO@BESTUROLOGY.NET
Contact: LUANDA SIANO, PA 305-822-7227 LUANDA@BESTUROLOGY.NET
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02381990
Other Study ID Numbers URN-13-1010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Non identifiable pertinent information will be shared for other scientists to evaluate other pertinent questions
Responsible Party Urological Research Network, LLC
Study Sponsor Urological Research Network, LLC
Collaborators Not Provided
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
PRS Account Urological Research Network, LLC
Verification Date September 2021