NCT05241236 · Urological Research Network, LLC
MRI/Ultrasound Fusion Guided Laser Ablation of Prostate Cancer
(MRFLA)
What this study is about
This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer.
View original scientific description
This serves as a registration trial. It aims to record short, intermediate, and long-term outcomes of patients treated with targeted laser ablation of biopsy confirmed prostate cancer.
Interventions
DEVICE
Image Fusion (MR/US) Software Registration Guided Laser Ablation of Prostate Cancer
Subjects diagnosed by a transperineal fusion or random transperineal or random transrectal prostate biopsy. Laser treatment plan generated by biopsy results +/- MRI is uploaded into the device. In procedure suite, a transperineal anesthetic block is conducted following by Bianco - USPTO PCT/US18/24404. On lithotomy a transrectal ultrasound probe is advanced, the prostate scanned. The images are acquired by fusion device. Co-registration is performed by surgeon delimiting boundaries of prostate. Medical device delivers real-time fusion guidance outlining prostate contours, ablation goals and laser introduce location. Surgeon executes plan or adjust as needed. Surgeon activates laser device, performs ablation monitored by medical device in real-time. The fusion device will deliver great perspective between the ablation areas and critical anatomical landmarks such as: NVB, membranous urethra, etc. Patient is dismissed to the recovery room and discharged afterwards
Primary outcome measures
Primary Oncological Control
Time frame: 1 Year
Negative CANCER Rate in treated area after fusion biopsy
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men between 50 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and \<50% positive core rate by prostate lobe
- Men older than 65 years of age with clinical diagnosis of prostate cancer \<50% positive core rate by prostate lobe
- Absence of extra-capsular extension
- Absence of seminal vesicle invasion
- Absence of regional or distant metastatic disease
- Multiparametric MRI of the prostate performed either before the biopsy or \>10 weeks after prostate biopsy
- Treated with Cryotherapy of the prostate
- Treatment based on co-registration between MP-MRI and Prostate Ultrasound
Exclusion criteria
- Prior treatment of prostate cancer in the form of surgery.
- Performance status greater than 0 based on ECOG criteria
- Mental status impairment
Where
- Miami Lakes, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 26, 2023 · Source of record for eligibility and locations