Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter.
Ian M Thompson, Donna K Pauler, Phyllis J Goodman...
https://pubmed.ncbi.nlm.nih.gov/15163773Actively Recruiting
Phase Not Applicable
Age: 40Years - 85Years
MALE
ID07339943
Micro-ultrasound-Guided Focal Laser Ablation Treatment for Management of Intermediate-Risk Prostate Cancer: Evaluation of Safety and Effectiveness
Led by University Health Network, Toronto · Updated on 2026-01-14
7
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
E
Exact Imaging
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Micro-Ultrasound Guided Focal Laser Ablation (MicroUSgFLA) as a treatment for men with intermediate-risk prostate cancer. This study aims to determine if this minimally invasive procedure can safely delay or avoid the need for more invasive treatments like surgery or radiation. The research focuses on men diagnosed with intermediate-risk prostate cancer to explore a simpler alternative to current options. Participants will receive MicroUSgFLA treatment using the TRANBERG|CLS Thermal Therapy device, which targets cancerous areas in the prostate guided by micro-ultrasound imaging. This single-arm study involves treating patients and then assessing them through MRI scans, biopsies, and PSA blood tests at six months after treatment. The procedure is designed to be less complex than MRI-guided treatments and may be accessible in community settings. During the study, participants will complete questionnaires about urinary and erectile function before treatment. Follow-up assessments include monitoring PSA levels, imaging, and biopsies to evaluate the treatment's technical success and impact on prostate cancer. The study's main outcomes are measured over six months, with safety and effectiveness closely monitored by the research team.
CONDITIONS
Brief Title
Micro-ultrasound-Guided Focal Laser Ablation for Intermediate-Risk Prostate Cancer: Safety & Effectiveness
Who Can Participate
Age: 40Years - 85Years
MALE
Eligibility Criteria
You may qualify if you...
- Men aged 40 to 80 years
- Histologically confirmed intermediate-risk prostate cancer with Gleason score 7 and primary grade 3
- Clinical stage T1c or T2 prostate cancer
- MRI or MicroUS site suspicious for cancer or cancer localized to one prostate lobe
- Maximum tumor size on MRI or MicroUS of 15 mm or less
- Suspicious site on imaging must match sector positive for cancer on biopsy
- Prostate specific antigen (PSA) level less than 15 ng/mL
- Completion of IPSS, ICIQ-UI-SF, and IIEF-15 questionnaires before procedure
- Life expectancy greater than 10 years based on non-prostate cancer co-morbidities
You will not qualify if you...
- Tumor size on MRI or MicroUS greater than 15 mm
- Medically unfit for focal prostate therapy
- Unable or unwilling to give informed consent
- Prior androgen suppression therapy
- Previous or current chemotherapy for prostate cancer
- Prior prostate surgery including HIFU, TUNA, RITA, microwave, cryotherapy, or other curative treatments
- Prior radiation therapy to prostate or pelvis
- Conditions or history that may affect study results or increase risks (e.g., significant cardiovascular conditions, allergies)
- History of non-compliance with medical therapy or recommendations
- Unable or unwilling to complete self-assessment questionnaires
- Chronic or acute prostatitis, neurogenic bladder, urinary tract infection, sphincter abnormalities, or any urinary symptoms preventing normal urination
- Participation in another clinical study or investigational treatment within past 90 days
- Contraindications to MRI such as pacemaker, hip prosthesis, severe claustrophobia, brain aneurysm clip, or allergy to MRI contrast agent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive Micro-Ultrasound Guided Focal Laser Ablation treatment for intermediate-risk prostate cancer.
Visits as needed for treatment and monitoring during the 6-month period
Follow-up
Duration - Assessment at 6 months after treatment
Participants are assessed by MRI, biopsy, and PSA testing to evaluate treatment safety and effectiveness.
1 visit (in-person) at 6 months
Trial Site Locations
Total: 1 location
1
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
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Research Team
K
Kateri Corr
S
Sangeet Ghai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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