Laser therapy for prostate cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.