What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as radical prostatectomy and radiation therapy, often result in significant side effects. Radical prostatectomy can lead to urinary incontinence and sexual dysfunction, with some patients experiencing persistent issues even after two years. Radiation therapy may cause bowel symptoms like urgency and frequency, as well as sexual dysfunction, which can stabilize over time but may still persist. Ablative techniques, including laser-induced thermal therapy, aim to minimize these side effects by sparing critical structures, but long-term data on their efficacy and safety are still limited.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including various forms of ablative techniques. While specific FDA approvals for laser-induced thermal therapy like Trans-perineal Focal Laser Ablation (FLA) are not detailed, other minimally invasive procedures such as high-intensity focused ultrasound (HIFU) and cryotherapy have been approved. These treatments aim to destroy cancerous tissue with minimal impact on surrounding structures. Additionally, systemic therapies like androgen deprivation therapy (ADT), abiraterone, enzalutamide, and radioligand therapy with lutetium Lu 177 vipivotide tetraxetan have been approved for advanced stages of prostate cancer.

What other types of research exist?

Promising, novel alternatives to Trans-perineal Focal Laser Ablation for prostate cancer patients include: 1) Magnetic Resonance Guided Focused Ultrasound (MRgFUS), which uses MRI for precise targeting and real-time monitoring of thermal ablation, preserving adjacent normal tissue. 2) High-Intensity Focused Ultrasound (HIFU), which non-invasively targets and destroys cancerous tissue using focused ultrasound waves. Both methods aim to minimize side effects and improve treatment outcomes.

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Procedure

Focal Laser Ablation for Prostate Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for prostate cancer include radical prostatectomy, radiation therapy (RT), and focal therapies like Trans-perineal Focal Laser Ablation (FLA). Radical prostatectomy involves surgically removing the prostate gland, which directly eliminates the cancerous tissue but can impact urinary and sexual function. Radiation therapy uses high-energy rays to kill cancer cells, which can affect surrounding tissues, leading to bowel and sexual dysfunction. FLA, a focal therapy, uses laser-induced thermal energy to precisely target and destroy cancerous tissue while sparing surrounding structures, potentially preserving urinary and sexual function better than more invasive treatments. Understanding these mechanisms helps patients and doctors choose treatments that balance cancer control with quality of life considerations.

N/A

Recruiting

Research Sponsored by Genesis Research LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new laser treatment for men with early-stage prostate cancer. The treatment uses ultrasound to guide the laser, making it more precise and safer. The goal is to see if this method is effective and safe, while also preserving sexual and urinary functions. Photodynamic therapy has been studied as a possible treatment for both recurrent and primary prostate cancer.

Who is the study for?

Men aged 40-85 with low-risk or favorable intermediate risk prostate cancer, PSA <20 ng/ml, and clinical tumor stage T2b or less. Candidates must have a lesion visible on micro-ultrasound and MRI, be able to undergo local anesthesia and Nitrous Oxide sedation, have normal rectal anatomy, and lesions not exceeding 50% of the lobe volume.

What is being tested?

The trial tests trans-perineal focal laser ablation (FLA) using the TRANBERG Thermal Therapy System combined with high frequency micro-ultrasound imaging for targeted treatment of localized prostate cancer lesions. It aims to improve safety, efficacy while preserving sexual function and minimizing incontinence.

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, risks associated with local anesthesia or Nitrous Oxide sedation. There's also a possibility of temporary urinary incontinence or changes in sexual function due to proximity to sensitive structures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and Tolerability: Number of Adverse Events Related to the Treatment

Secondary study objectives

Efficacy: Extent of Tumor Ablation by Laser Application

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Laser AblationExperimental Treatment1 Intervention

TRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include radical prostatectomy, radiation therapy (RT), and focal therapies like Trans-perineal Focal Laser Ablation (FLA). Radical prostatectomy involves surgically removing the prostate gland, which directly eliminates the cancerous tissue but can impact urinary and sexual function. Radiation therapy uses high-energy rays to kill cancer cells, which can affect surrounding tissues, leading to bowel and sexual dysfunction. FLA, a focal therapy, uses laser-induced thermal energy to precisely target and destroy cancerous tissue while sparing surrounding structures, potentially preserving urinary and sexual function better than more invasive treatments. Understanding these mechanisms helps patients and doctors choose treatments that balance cancer control with quality of life considerations.