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New treatment option for Prostate Cancer
Official title TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
ClinicalTrials.gov ID: NCT05698576
What this study is testing
- What it's testing
- This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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 \ 45
You likely can't join if
- 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
See the full eligibility 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 \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hialeah, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hialeah, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.