low accrual

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.

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 vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for various medical specialties. The Avenda Health Unfold-AI Software (K221624) is an Artificial Intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow that is also FDA 510(k) cleared. The Unfold-AI Software will be utilized along with the FocalPoint System and is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. This feasibility investigation will determine whether the FocalPoint System used with Unfold-AI can be used to ablate prostate tissue in men with prostate cancer while leaving critical structures (urethra, rectal wall) undamaged.

This is an open-label feasibility/pilot study to evaluate the safety and feasibility of the FocalPoint System with Unfold-AI. In this study, the investigators intend to use the Unfold-AI 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. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region. 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 HRQOL questionnaires. Post-treatment MRI findings, fusion biopsy results and biomarker (PSA) kinetics will also be monitored. Subjects eligible for repeat FLA (re-ablation) are those who still continue to meet Inclusion and Exclusion Criteria at Months 6 or 12 post-FLA treatment (See Sections 3.0 Inclusion Criteria, 4.0 Exclusion Criteria, and 6.4.7 Repeat FLA (re-ablation)). Subjects may undergo only one re-ablation on the study.

This study will cover pre-treatment through 12 months following FLA treatment or repeat FLA (re-ablation) treatment. The study also has a long-term follow-up data collection period of up to 10 years following a subject's last study visit.

The primary endpoint will be safety. Safety will be determined by the number, type, and severity of adverse events incurred by subjects.

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)

a prostate gland must be present