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Procedure
Focal Laser Ablation for Prostate Cancer
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
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
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Laser AblationExperimental Treatment1 Intervention
TRANBERG® Transperineal Micro Ultrasound guided laser ablation of Prostate Cancer.
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.
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Who is running the clinical trial?
Genesis Research LLCLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation treatment in my pelvic area.I have had surgery on my prostate before.My prostate cancer is aggressive (Gleason score 7 or higher).I am a man with early-stage prostate cancer, confirmed by recent MRI and ultrasound.I have a narrowed urethra.I can read and understand English and am willing to sign the consent form.I can undergo procedures with local anesthesia.I can be sedated with Nitrous Oxide.I am on blood thinner medication.My prostate cancer has come back after treatment.My prostate is larger than usual.My rectal cancer is in an early stage, not larger than T2b.My prostate cancer has spread beyond the prostate.I have had treatments for prostate cancer, including surgery or hormone therapy.I need assistance with daily activities due to my health condition.I am a man aged between 40 and 85.My prostate cancer is multifocal and not the least aggressive type.My rectal anatomy is normal.My MRI shows that my brain lesion is on one side and takes up less than half of the lobe.My cancer treatment area is safely distanced from vital parts.The tumor in my body is at least 8mm away from sensitive areas.I cannot stay in a specific position for surgery with sedation for more than 90 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: Laser Ablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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