NCT05698576 TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer
| NCT ID | NCT05698576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Urological Research Network, LLC |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-03-16 |
| Primary Completion | 2023-01-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-03-16 with a primary completion date of 2023-01-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Fernando J Bianco, MD
PRINCIPAL INVESTIGATOR
Urological Research Network
Frequently Asked Questions
Who can join the NCT05698576 clinical trial?
This trial is open to male participants only, aged 50 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05698576 currently recruiting?
Yes, NCT05698576 is actively recruiting participants. Contact the research team at cielo@besturology.net for enrollment information.
Where is the NCT05698576 trial being conducted?
This trial is being conducted at Hialeah, United States.
Who is sponsoring the NCT05698576 clinical trial?
NCT05698576 is sponsored by Urological Research Network, LLC. The principal investigator is Fernando J Bianco, MD at Urological Research Network. The trial plans to enroll 20 participants.
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