TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer

Launched by UROLOGICAL RESEARCH NETWORK, LLC · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat prostate cancer using a technique called Laser Induced Thermal Therapy (TFA-LITT). The goal is to safely and effectively target and destroy cancer tumors in the prostate while preserving the surrounding healthy tissue and minimizing side effects. The study will involve men aged 50 to 80 who have low to intermediate risk prostate cancer. Participants will be treated in a doctor's office under local anesthesia, which means they will be awake but won't feel pain during the procedure.

To qualify for the trial, participants should be able to give informed consent and complete follow-up visits. They must have certain health conditions, such as not having urinary retention and having prostate cancer that meets specific criteria. Throughout the study, participants will have regular check-ups to monitor their cancer control and any effects on their urinary and sexual function. This trial is important because it aims to find a treatment option that reduces the risks of traditional surgeries, helping men maintain a better quality of life after treatment.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Willing and able to sign informed consent
• • Subject is able and willing to complete all procedure and follow-up visits indicated in the protocol
• • Absence of urinary retention
• • Prostate volume: ≥ 18 and ≤ 100 cc, measured by transrectal ultrasound
• • Serum creatinine levels \<2 ng/dl and GFR \> 45
• • Serum PSA levels \< 20 ng/ml
• • Multiparametric prostate MRI with piRADS scores 3-5
• • Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI
• • Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of the gland volume by MRI evaluation
• Exclusion Criteria:
• • Post-void residual (PVR): \> 250 mL or \> 50% of voided volume
• • Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation
• • Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
• • Evidence of neurogenic bladder determined by urodynamics studies
• • Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days
• • Active urinary tract infection determined by urinary cultures
• • SHIM score \<14
• • IPSS score \>23
• • Acute prostatitis
• • Macroscopic hematuria without a known contributing factor
• • History of colorectal carcinoma with anterior perineal resection of rectum
• • History of pelvic radiation therapy or radical pelvic surgery
• • History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
• • Bladder stones
• • Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)
• • Diagnosed or suspected bleeding or coagulopathic disorder such as hemophilia, ITP, TTP
• • Medical contraindication to being subjected to local anesthesia