MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

Last updated: January 24, 2023
Sponsor: Urological Research Network, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT05241236
URN-20-014
  • Ages > 50
  • Male

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men between 50 and 65 years of age with a clinical diagnosis of prostate cancer withLow 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 weeksafter prostate biopsy
  • Treated with Cryotherapy of the prostate
  • Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion

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 Design

Total Participants: 5000
Study Start date:
November 15, 2020
Estimated Completion Date:
November 30, 2038

Study 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

Connect with a study center

  • Urological Research Network

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

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