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MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

NCT05241236 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2023-01-26

No results posted yet for this 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

Conditions

  • Neoplasms Prostate
  • Cancer of the Prostate

Interventions

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

Sponsors & Collaborators

  • Urological Research Network, LLC

    lead OTHER

Principal Investigators

  • FERNANDO J BIANCO, MD · UROLOGICAL RESEARCH NETWORK

  • EUSEBIO LUNA, MD · UROLOGICAL RESEARCH NETWORK

  • Isabel H Lopez, MD · UROLOGICAL RESEARCH NETWORK

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-15
Primary Completion
2025-11-30
Completion
2038-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05241236 on ClinicalTrials.gov