This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer (MRFLA)

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.
 
ClinicalTrials.gov Identifier: NCT05241236
Recruitment Status : Recruiting
First Posted : February 15, 2022
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Urological Research Network, LLC

Brief Summary:
This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. Outcomes will be categorized as: 1- Procedure Related, 2- Perioperative - Adverse Events that may occur within 90 days, 3-Oncologic: Recurrence of cancer in treatment area, de-novo tumors, conversion to radical surgery, radiation or cryoablation, emergence of metastasis, 4- Functional: Sexual and Urinary function following treatment

Condition or disease Intervention/treatment
Neoplasms Prostate Cancer of the Prostate Device: Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer

Detailed Description:

CLINICAL REGISTRY OBSERVATION NATURE

This serves as a registration trial evaluating short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer. The primary outcome measure is 1-year oncological control of the targeted ablated area. The following secondary aims are sought: PROCEDURE RELATED: tolerability, feasibility, pain during this office-based procedure. PERIOPERATIVE: Adverse Events (AEs) and Series AEs profile during the initial 90 days after the procedure. ONCOLOGIC - In addition to primary aim, determine risk and rate of emergence of de-novo tumors (so called Outfield Recurrence) at the 1 year fusion biopsy mark and overtime. Will also observe rate of progression locally and systemically. Conversion to whole gland treatment - surgery extraction, radiation or whole gland cryoablation is of particular interest as is the initiation of androgen suppression (castration). Moreover, the investigators will evaluate the impact of MRI in assessing tumor locations and of software registration guiding the location and extent of ablation of the laser ablation over fixed time intervals. Finally, incidence of metastatic disease - non castrate and castrate - as well as cancer specific and overall survival at 5, 10 and 15 years post procedure. FUNCTIONAL OUTCOMES - determine urinary function and sexual function including incidence of ejaculation, and climacturia at months 3, 6 and 12. These outcomes will then measured yearly for the extent of the study

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Office Based MRI/Ultrasound Guided Prostate Cancer Ablation: Outcomes Registry
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2038

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Device: Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
    Subjects diagnosed by a transperineal fusion or random transperineal or random transrectal prostate biopsy. Laser treatment plan generated by biopsy results +/- MRI is uploaded into the device. In procedure suite, a transperineal anesthetic block is conducted following by Bianco - USPTO PCT/US18/24404. On lithotomy a transrectal ultrasound probe is advanced, the prostate scanned. The images are acquired by fusion device. Co-registration is performed by surgeon delimiting boundaries of prostate. Medical device delivers real-time fusion guidance outlining prostate contours, ablation goals and laser introduce location. Surgeon executes plan or adjust as needed. Surgeon activates laser device, performs ablation monitored by medical device in real-time. The fusion device will deliver great perspective between the ablation areas and critical anatomical landmarks such as: NVB, membranous urethra, etc. Patient is dismissed to the recovery room and discharged afterwards
    Other Name: Intervention of Interest: Prostate Cancer Laser Ablation


Primary Outcome Measures :
  1. Primary Oncological Control [ Time Frame: 1 Year ]
    Negative CANCER Rate in treated area after fusion biopsy


Secondary Outcome Measures :
  1. Perioperative Outcomes [ Time Frame: 90 days ]
    Rate of Adverse Events and Serious Adverse Events following CTCAE v5 classification

  2. Urinary Function [ Time Frame: 5 years ]
    Rate of AUA symptoms score less than 7 (Scale 0-35).

  3. Sexual Function [ Time Frame: 5 years ]
    Rate of Sexual Inventory for men scores above 15 (Scale 1-25)

  4. Radiological Cancer Control [ Time Frame: 5 Years ]
    Rate of Detection of discrete lesions following multi-parametric prostate MRI


Other Outcome Measures:
  1. Rate of Conversion to Whole gland treatment - Salvage Treatment [ Time Frame: 10 years ]
    Conversion to radical surgery or radiation or cryoablation

  2. Rate of development of metastasis [ Time Frame: 10 years ]
    Detection of metastatic disease



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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 50 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

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): NCT05241236


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

Locations
Layout table for location information
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         
Sub-Investigator: EUSEBIO J LUNA, MD         
Sub-Investigator: ALBERTO LOPEZ-PRIETO, MD         
Sub-Investigator: DAYRON RODRIGUEZ, MD         
Sub-Investigator: JUAN I MARTINEZ-SALAMANCA, MD         
Sub-Investigator: SIMON PAZ, MD         
Sponsors and Collaborators
Urological Research Network, LLC
Investigators
Layout table for investigator information
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:

Layout table for additonal information
Responsible Party: Urological Research Network, LLC
ClinicalTrials.gov Identifier: NCT05241236    
Other Study ID Numbers: URN-20-014
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023
Individual Participant Data (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
Supporting Materials: Clinical Study Report (CSR)
Time Frame: 6 years
Access Criteria: institutional agreement, HIPPA compliance

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Urological Research Network, LLC:
Prostate
PSA
FUSION
Ultrasound
MRI
Cancer
Laser
Outcomes
Recurrence
QOL, Quality of Life
Urinary function
Sexual Function
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases