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Focal Laser Ablation of Prostate Cancer: A Feasibility Study Using MRI/US Image Fusion for Guidance

About

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 identify cancer margins and create ablation treatment plans and use the FocalPoint System to deploy and monitor thermal energy in cancerous regions of the prostate. Subjects will be assessed at 1 week, 1 month, and every 3 months until one-year post-FLA treatment(s) to be monitored for adverse events and complete quality-of-life questionnaires.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Pilot/Feasibility

Eligibility

Gender
Male
Healthy Volunteers
No
Minimum Age
40 Years
Maximum Age
85 Years

Inclusion Criteria:

  • 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 Criteria:

  • 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)

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Study Stats
Protocol No.
22-001942
Category
Prostate Cancer
Contact
SAMANTHA GONZALEZ
Location
  • UCLA Westwood
For Providers
NCT No.
NCT06047509
For detailed technical eligibility, visit ClinicalTrials.gov.