Recruiting

Laser Ablation

Sponsor:

Urological Research Network, LLC

Code:

NCT05241236

Conditions

Neoplasms Prostate

Cancer of the Prostate

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer

Study Details

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

Conditions

Neoplasms Prostate

Cancer of the Prostate

Study ID

NCT05241236

Start date

Nov 15, 2020

Status verified date

Jan, 2023

Completion date

Nov, 2038

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Primary Oncological Control [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

CIELO D GUERRA, BS

305-515-9887CIELO@BESTUROLOGY.NET

LUANDA SIANO, PA

305-822-7227LUANDA@BESTUROLOGY.NET

Locations

Urological Research Network

Recruiting

Miami Lakes, Florida, United States, 33016

Contacts

CIELO D GUERRA, BS

305-515-9887CIELO@BESTUROLOGY.NET

Principal Investigator:

FERNANDO J BIANCO, MD

More Information

Sponsor

Urological Research Network, LLC

Last update posted

Jan 26, 2023

Last verified

Jan, 2023

Keywords

  • Prostate
  • PSA
  • FUSION
  • Ultrasound
  • MRI
  • Cancer
  • Laser
  • Outcomes
  • Recurrence
  • QOL, Quality of Life
  • Urinary function
  • Sexual Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urological Research Network, LLC on 2023-01-26.