MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Urological Research Network, LLC
Study ID
NCT05241236
Status
Recruiting
Apply to this trial

Conditions

  • Cancer of the Prostate
  • Neoplasms Prostate

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Nov 15, 2020
Status verified
Jan 2023
Primary completion
Nov 30, 2025
Completion
Nov 30, 2038

Study Design

Enrollment
5,000 participants (estimated)

Primary Outcome Measure

Primary Oncological Control [ Time Frame: 1 Year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Urological Research NetworkMiami LakesFlorida33016
CIELO D GUERRA, BS
[email protected]
305-515-9887
FERNANDO J BIANCO, MD (PRINCIPAL_INVESTIGATOR)
EDWARD L GHEILER, MD (SUB_INVESTIGATOR)
ARIEL M KAUFMAN, MD (SUB_INVESTIGATOR)
EUSEBIO J LUNA, MD (SUB_INVESTIGATOR)
ALBERTO LOPEZ-PRIETO, MD (SUB_INVESTIGATOR)
DAYRON RODRIGUEZ, MD (SUB_INVESTIGATOR)
JUAN I MARTINEZ-SALAMANCA, MD (SUB_INVESTIGATOR)
SIMON PAZ, MD (SUB_INVESTIGATOR)

Find similar trials in Miami Lakes, FL

By research site
Urological Research Network· Miami Lakes, FL

Related Studies