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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
Study Summary
This trial aims to evaluate trans-perineal FLA as an alternative to traditional therapies for low-risk and favorable intermediate-risk prostate cancer patients.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability: Number of Adverse Events Related to the Treatment
Secondary outcome measures
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.
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial accept applicants who have attained the age of majority?
"This trial seeks out individuals aged between 40 and 85 years old."
Answered by AI
Am I eligible to join this experiment?
"This medical trial is seeking a cohort of 15 individuals with prostate cancer that are between 40 and 85 years old."
Answered by AI
Is this research endeavor looking for new test subjects at the moment?
"According to the details hosted on clinicaltrials.gov, this research project is actively enrolling patients. The recruitment process began on April 30th 2023 and was last revised on April 12th of the same year."
Answered by AI
To what extent are participants being treated in this research project?
"Affirmative. Per the clinicaltrials.gov listing, this medical study is enrolling 15 patients from one site and was originally posted on April 30th 2023 with updates occurring as recently as April 12th 2023."
Answered by AI
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