MRFLA: MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

Sponsor

Urological Research Network, LLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT05241236

Collaborator

(none)

5,000

Enrollment

Location

215.5

Anticipated Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 15, 2020

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 1, 2038

Outcome Measures

Primary Outcome Measures

Primary Oncological Control [1 Year]
Absence of prostate cancer in treated area after fusion biopsy

Secondary Outcome Measures

Perioperative Outcomes [90 days]
Adverse Events and Serious Adverse Events following CTCAE v5 classification
Urinary Function [5 years]
Evaluation of urinary function using AUA symptoms scores (Scale 0-35).
Sexual Function [5 years]
Evaluation of sexual function using Sexual Inventory for men questionnaires (Scale 1-25)
Radiological Cancer Control [5 Years]
Detection of discrete lesions following multi-parametric prostate MRI

Other Outcome Measures

Salvage Treatment [5 years]
Conversion to radical surgery or radiation or cryoablation

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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