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, we 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

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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