Laser therapy for prostate cancer treatment
TRANBERG® Transperineal MR/US Focalyx Fusion Laser--Induced Thermal Therapy in the Office Setting Under Local Anesthesia
This study is testing a new laser treatment for men aged 50 to 80 with low to intermediate risk prostate cancer to see if it is a safer and less invasive option than traditional surgery or radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | Male |
| Sponsor | Urological Research Network, LLC Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Hialeah, Florida) |
| Trial ID | NCT05698576 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and tolerance of a novel laser-induced thermal therapy (TFA-LITT) for men aged 50 to 80 with low to intermediate risk prostate cancer. Conducted in an office setting under local anesthesia, the study utilizes advanced fusion imaging to guide the targeted ablation of prostate tumors. The aim is to provide a less invasive treatment option compared to traditional radical surgery or radiation, which often lead to significant side effects. Participants will undergo a thorough assessment to ensure they meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are men aged 50 to 80 with low to intermediate risk prostate cancer and specific prostate volume and PSA levels.
Not a fit: Patients with previous prostate cancer interventions or significant urinary retention may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a minimally invasive treatment option that reduces the risk of adverse effects associated with conventional prostate cancer treatments.
How similar studies have performed: While laser ablation techniques have been used in various organs, this specific application for prostate cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hialeah, Florida
- Urology Specialist Group — Hialeah, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Fernando J Bianco, MD — Urological Research Network
- Study coordinator: Cielo D Guerra, BS
- Email: cielo@besturology.net
- Phone: 786-431-2014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.