RecruitingNCT05241236

MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

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

Sponsor

Urological Research Network, LLC

Enrollment

5,000 participants

Start Date

Nov 15, 2020

Study Type

OBSERVATIONAL

Conditions

Cancer of the Prostate Neoplasms, Prostate

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

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a minimally invasive procedure called MRI/ultrasound fusion-guided laser ablation — where a laser is used to destroy prostate cancer tumors precisely, guided by advanced imaging — as a treatment for low-to-intermediate risk prostate cancer. **You may be eligible if...** - You are a man with a clinical diagnosis of prostate cancer that is low or intermediate risk - Less than 50% of your prostate biopsy cores on one side are positive for cancer - You have no signs of cancer spread beyond the prostate capsule - You have undergone a multiparametric MRI of the prostate **You may NOT be eligible if...** - You have already had prostate cancer surgery - You have significant health or cognitive limitations affecting daily activities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImage 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