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

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

Office Based MRI/Ultrasound Guided Prostate Cancer Ablation: Outcomes Registry

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

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
        • Sub-Investigator:
          • ALBERTO LOPEZ-PRIETO, MD
        • Sub-Investigator:
          • DAYRON RODRIGUEZ, MD
        • Sub-Investigator:
          • JUAN I MARTINEZ-SALAMANCA, MD
        • Sub-Investigator:
          • SIMON PAZ, 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

50 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 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

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
Primary Oncological Control
Time Frame: 1 Year
Negative CANCER Rate in treated area after fusion biopsy
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Outcomes
Time Frame: 90 days
Rate of Adverse Events and Serious Adverse Events following CTCAE v5 classification
90 days
Urinary Function
Time Frame: 5 years
Rate of AUA symptoms score less than 7 (Scale 0-35).
5 years
Sexual Function
Time Frame: 5 years
Rate of Sexual Inventory for men scores above 15 (Scale 1-25)
5 years
Radiological Cancer Control
Time Frame: 5 Years
Rate of Detection of discrete lesions following multi-parametric prostate MRI
5 Years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Conversion to Whole gland treatment - Salvage Treatment
Time Frame: 10 years
Conversion to radical surgery or radiation or cryoablation
10 years
Rate of development of metastasis
Time Frame: 10 years
Detection of metastatic disease
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)

November 15, 2020

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

November 1, 2038

Study Registration Dates

First Submitted

September 26, 2021

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 15, 2022

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-20-014

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

IPD Sharing Time Frame

6 years

IPD Sharing Access Criteria

institutional agreement, HIPPA compliance

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

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

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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