Status:
ACTIVE_NOT_RECRUITING
Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40-85 years
Phase:
NA
Brief Summary
This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with UnfoldAI. In this study, the investigators intend to use the UnfoldAI software to ide...
Detailed Description
The Avenda Health FocalPoint System (K201687) is a laser-based interstitial irradiation/thermal soft-tissue ablation system that is FDA 510(k) cleared for surgical applications requiring the vaporizat...
Eligibility Criteria
Inclusion
- Subjects with organ-confined prostate cancer (clinical stage ≤ T2b, Gleason =7)
- Age 40 to 85 years of age
- Multi-parametric MRI read at study site within 9 months of study treatment, demonstrating a Region of interest (ROI) of MRI (PIRADSv2 \> Grade 3)1
- Prostate volume 20cc to 80cc
- MRI/ultrasound fusion biopsy with ≥ 10 systematic biopsy cores and ≥ 2 targeted biopsy cores from above MRI-derived ROI within 6 months of study treatment\*
- Histologically confirmed adenocarcinoma from targeted biopsy cores
- Overall Gleason = 3+4 or 4+3
- Subjects desire focal therapy and decline conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery, and hormone therapy)
- Treatment plan that allows for treatment of lesion while still maintaining a 4mm safety margin from the rectal wall and urethra
- Signed informed consent for the FLA treatment through follow-up per study protocol
- For subjects under consideration for repeat FLA, the post-treatment MRI and biopsies done at Months 6 and 12 study visits may be used for these criteria.
Exclusion
- Any significant cancer outside of the intended treatment zone, defined as Gleason score ≥ 7
- \< 10 years life expectancy
- Any medical condition that would compromise the subject's ability to safely participate in the study
- Active bleeding disorder
- Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
- Use of aspirin, unless it can be temporarily stopped for a window of at least 14 days prior to FLA procedure
- Use of NSAIDS (except aspirin), Vitamin E, multivitamins, and herbal products, unless they can be temporarily stopped for at least 7 days prior to FLA procedure
- Active urinary tract infection
- Active prostate abscess, prostatitis, or neurogenic bladder
- Any prior treatment for prostate cancer, including:
- Radical prostatectomy
- Radiation therapy (external beam or brachytherapy)
- Cryotherapy
- High intensity focused ultrasound (HIFU) treatment
- Photodynamic therapy
- Androgen deprivation therapy
- Focal Laser Ablation (acceptable for enrolled subjects under consideration for repeat FLA)
- Prior prostate, bladder neck, or urethral stricture surgery
- Any prostate debulking procedure, including transurethral resection of prostate, photovaporization, or electrovaporization
- Transurethral incision of bladder neck
- Urethral stricture dilation or reconstruction
- Use of 5-alpha reductase inhibitors within 6 months of treatment
- Prior significant rectal surgery (hemorrhoidectomy is acceptable)
- Active rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
- Active inflammatory bowel disease
- Urinary tract or rectal fistula
- Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery.
- Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis, MRI-unsafe aneurysm clips)
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2027
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06047509
Start Date
September 14 2023
End Date
October 1 2027
Last Update
November 10 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095-1406