NCT05698576Recruiting
TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
TRANBERG® Transperineal MR/US Focalyx Fusion Laser--Induced Thermal Therapy in the Office Setting Under Local Anesthesia
Source: ClinicalTrials.gov · Last updated 26 Jan 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 19 Jan 2022
- Start date
- Mar 2022
- Primary completion date
- Jan 2023
- Lead sponsor
- Urological Research Network, LLC
- Diseases
- Prostate cancer
- NCT number
- NCT05698576
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Mar 2022 to the primary completion date, Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation
- Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days
- History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
Other illness
- Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
- Active urinary tract infection determined by urinary cultures
- History of colorectal carcinoma with anterior perineal resection of rectum
- History of pelvic radiation therapy or radical pelvic surgery
- 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
Other
- Post-void residual (PVR): \> 250 mL or \> 50% of voided volume
- Evidence of neurogenic bladder determined by urodynamics studies
- SHIM score \<14
- IPSS score \>23
- Acute prostatitis
- Macroscopic hematuria without a known contributing factor
- Bladder stones
- Medical contraindication to being subjected to local anesthesia
Who the study is looking for
- 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
Age in the registry: 50 years to 80 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urology Specialist Group Coordinator of this site? Confirm its status | Hialeah | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.