Prostate Cancer · University Urology, PC

Focal Therapy for Prostate Cancer:
HIFU & NanoKnife (IRE)

Precisely targeted, minimally invasive treatments designed to destroy prostate cancer while protecting the tissues that matter most — urinary control, sexual function, and quality of life.

What is Focal Therapy?

Treating the Cancer. Sparing the Rest.

Traditional whole-gland treatments for prostate cancer — radical prostatectomy and radiation — treat the entire prostate. They are highly effective, but carry meaningful risks of long-term side effects, including urinary incontinence and erectile dysfunction.

Focal therapy takes a different approach. Using precise imaging and real-time guidance, we target and destroy only the cancerous tissue — the index lesion — while leaving healthy prostate tissue, nerves, and surrounding structures intact.

University Urology is the only practice in East Tennessee offering both primary and salvage focal therapy. All focal therapy cases are performed by Dr. James M. Bienvenu, a fellowship-trained urologic oncologist, at the University of Tennessee Medical Center in Knoxville.

University Urology Focal Therapy Program

East Tennessee's Only HIFU & NanoKnife Center

All procedures are performed at University of Tennessee Medical Center in Knoxville — with dedicated focal therapy procedure days and on-site surgical support.

Our program serves patients from across East Tennessee, Kentucky, Southwest Virginia, Western North Carolina, and Northern Georgia.

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Our Focal Therapy Options

HIFU & NanoKnife: Two Precision Technologies

We offer the two most established focal therapy platforms for prostate cancer. The right choice depends on tumor characteristics, prostate size, tumor location, and your individual goals — Dr. Bienvenu will determine which is most appropriate at your consultation.

Thermal Ablation
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HIFU — High-Intensity Focused Ultrasound

Sonablate® · FDA-cleared for prostate tissue ablation (2015)

HIFU uses precisely focused ultrasound waves to heat and destroy targeted prostate tissue. The energy converges at a single focal point, raising temperatures high enough to destroy cancer cells while leaving surrounding tissue unaffected.

Guidance:Real-time transrectal ultrasound with continuous tissue feedback
Location:University of Tennessee Medical Center, Knoxville
Setting:Outpatient — same-day procedure
Duration:1–3 hours depending on prostate size and treatment volume
Recovery:Normal activity within a few days for most patients
Radiation:None — does not limit future treatment options
Best for:Low- to intermediate-risk localized cancer; salvage after radiation failure

The Sonablate® system monitors real-time tissue changes throughout treatment and provides continuous ablation feedback, allowing Dr. Bienvenu to confirm adequate tissue destruction before concluding the case.

Non-Thermal Ablation

NanoKnife — Irreversible Electroporation (IRE)

AngioDynamics NanoKnife® · Non-thermal ablation technology

NanoKnife uses precisely delivered electrical pulses to permanently disrupt cancer cell membranes — irreversible electroporation (IRE). Unlike HIFU, NanoKnife is a non-thermal technology: it destroys tissue without heat, which is critical for tumors near sensitive structures.

Guidance:Ultrasound and fluoroscopic guidance with electrode array placement
Location:University of Tennessee Medical Center, Knoxville
Setting:Performed under general anesthesia
Duration:Approximately 1–2 hours
Recovery:Most patients go home the same or next day
Key advantage:Non-thermal — ideal for tumors near the urethra, neurovascular bundles, or rectum
Best for:Low- to intermediate-risk cancer in anatomically sensitive locations

Because NanoKnife does not rely on heat, it preserves the structural integrity of adjacent vessels, nerves, and ducts — a meaningful advantage when tumor location makes thermal ablation riskier.

Patient Selection

Who Is — and Who Is Not — a Candidate for Focal Therapy?

Focal therapy is not the right choice for every patient with prostate cancer. Proper patient selection is the single most important factor in achieving good outcomes. The criteria below are a general guide — your complete situation will be reviewed at your consultation.

✓  Likely a Good Candidate

  • Localized, low- to intermediate-risk disease — Gleason 3+3=6 or 3+4=7 (Grade Group 1–2)
  • Well-defined, discrete tumor on multiparametric MRI (mpMRI) with PI-RADS ≥ 3
  • Generally PSA under 10 ng/mL without high-risk biochemical features
  • Clinical stage T1c or T2a — no extraprostatic extension
  • Prostate volume compatible with device delivery (generally <60–70 cc for HIFU; NanoKnife is less size-dependent)
  • No lymph node or distant metastases on staging imaging
  • Strong desire to preserve urinary and sexual function with an acceptable oncologic tradeoff
  • Currently on active surveillance seeking a step-up short of radical therapy
  • Select intermediate-risk patients (Gleason 4+3=7; Grade Group 3) following multidisciplinary review

✕  Generally NOT a Good Candidate

  • High-risk or very high-risk disease — Gleason ≥ 8 (Grade Group 4–5); whole-gland treatment is typically indicated
  • Multifocal, diffuse cancer without a dominant index lesion
  • Extraprostatic extension, seminal vesicle invasion, or lymph node involvement (≥ T3 disease)
  • Distant metastases — focal therapy treats local disease only
  • Very large prostate (>80 cc) without prior volume reduction, particularly for HIFU
  • Prior rectal surgery or severe rectal pathology (relevant for transrectal HIFU delivery)
  • Inability to tolerate anesthesia or significant surgical comorbidities
  • Unwillingness to commit to active PSA surveillance and possible re-treatment after focal therapy

🔄  Salvage Focal Therapy: A Second Chance After Radiation

Both HIFU and NanoKnife can be used as salvage focal therapy for men with recurrent prostate cancer following prior radiation — including external beam radiation (EBRT) and brachytherapy. If your PSA is rising after radiation, focal therapy may provide effective local disease control with a more favorable side effect profile than salvage surgery or reirradiation. Outside biopsy pathology and prior imaging are required before scheduling a salvage consultation.


Before Your Appointment

What We Need to Evaluate You for Focal Therapy

To make the most of your consultation, please ensure the following are available before or at the time of your visit. Many referring offices can assist with transferring records.

1

Prostate Biopsy Pathology Report

A recent biopsy with Gleason grading is required. Transperineal biopsy is our preferred technique and can be arranged at University Urology if you have not yet had one. Molecular testing results (Oncotype DX, Decipher, Prolaris) are helpful when available.

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Multiparametric MRI (mpMRI) of the Prostate

A high-quality mpMRI with PI-RADS scoring is essential for focal therapy planning. Please bring the imaging disc or arrange a transfer. If no MRI has been performed, we can coordinate this prior to your consultation.

3

Recent PSA Lab Values

PSA trend over time is more informative than a single reading. Please bring any available PSA history, including post-biopsy values.

4

Prior Treatment Records (Salvage Cases)

If you have received prior radiation or other prostate treatments, please obtain those records including radiation planning documents, treatment summaries, and all subsequent PSA values.

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Staging Imaging (If Obtained)

Bone scan, CT, or PSMA PET results and images — if ordered by your referring provider — should be included in your records transfer.

Insurance & Coverage

Insurance Coverage for Focal Therapy Can Be Complex — We're Here to Help

We want to be straightforward with you: insurance coverage for focal therapy — particularly HIFU and NanoKnife — varies considerably by plan, carrier, and clinical indication. Some commercial payers cover these procedures broadly; others require prior authorization or classify them as investigational for certain risk categories. Medicare coverage for HIFU has expanded meaningfully in recent years, but is not universal across all plans.

This should not prevent you from exploring whether focal therapy is the right treatment for you. Our team has extensive experience navigating the prior authorization and appeals process, and we will work with you to understand your options clearly before you commit to any treatment decision.

Medicare

HIFU has established Medicare coverage. Coverage determinations are procedure-code and diagnosis specific. We verify your plan before scheduling.

Commercial Insurance

Coverage varies widely by carrier and plan. Some payers cover focal therapy broadly; others require peer-to-peer review or written appeal. Our team manages this on your behalf.

Prior Authorization

Many plans require prior authorization. We submit clinical documentation — pathology, imaging, and clinical rationale — to support approval.

If Coverage Is Denied

We will counsel you on appeals, self-pay pricing, and alternative treatment pathways that may be covered under your plan.

The bottom line: do not let coverage questions determine whether you come in for a consultation. A consultation with Dr. Bienvenu will clarify whether you are a candidate — and our team will work through the coverage picture with you before any procedure is scheduled.


Your Physician

Focal Therapy at University Urology

All focal therapy procedures are performed by Dr. James M. Bienvenu at the University of Tennessee Medical Center in Knoxville — the only physician in East Tennessee offering both HIFU and NanoKnife for prostate cancer.

JB

Dr. James M. Bienvenu, MD

Fellowship-Trained Urologic Oncologist · University of Tennessee Medical Center, Knoxville

Dr. Bienvenu specializes in advanced urologic oncology including focal therapy (HIFU and NanoKnife), radical cystectomy, RPLND, caval thrombectomy, and robotic surgery. He is recognized among Newsweek's America's Best Prostate Cancer Surgeons (2024). All focal therapy cases are performed at UTMC with dedicated procedure days available.

View Dr. Bienvenu's Full Profile →

Why University Urology

Comprehensive Prostate Cancer Care — All in One Practice

Focal therapy is one component of a full prostate cancer program. If your disease requires a different approach — or if focal therapy is followed by additional treatment — everything is available at UTMC.

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Only Regional HIFU & NanoKnife Center

The only practice in East Tennessee offering both technologies, performed at UTMC with dedicated procedure days.

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On-Site Transperineal Biopsy

If you need a biopsy before your focal therapy evaluation, we offer transperineal prostate biopsy at UTMC — the safest and most accurate technique available.

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Advanced Imaging Integration

MRI/ultrasound fusion capabilities and PSMA PET coordination for comprehensive staging and treatment planning.

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Multidisciplinary Cancer Team

We coordinate closely with medical and radiation oncology partners to ensure your treatment plan is complete before and after focal therapy.

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Salvage & Recurrent Disease

We evaluate and treat patients with rising PSA after prior radiation or other prostate treatments — a complex area where few practices have meaningful experience.

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Insurance Navigation Support

Our team manages prior authorization, appeals, and coverage questions so you can focus on making the best treatment decision — not paperwork.


Frequently Asked Questions

Common Questions About Focal Therapy

Is focal therapy as effective as radical prostatectomy or radiation?
For carefully selected patients with low- to intermediate-risk, localized disease, focal therapy achieves cancer control rates comparable to whole-gland treatment. The key is proper patient selection. Dr. Bienvenu will give you an honest assessment of the oncologic tradeoff for your specific situation.
What are the risks and side effects?
Compared to radical prostatectomy and radiation, focal therapy carries significantly lower rates of urinary incontinence and erectile dysfunction. Short-term side effects may include temporary urinary frequency, mild discomfort, and occasionally a temporary catheter for a few days. Serious complications are uncommon. Specific risk profiles vary between HIFU and NanoKnife based on tumor location and technique.
What happens if focal therapy doesn't fully treat the cancer?
Focal therapy does not close the door on other treatments. If PSA rises or surveillance biopsy shows residual disease, options include repeat focal therapy, active surveillance, radiation, or surgery. Because focal therapy does not involve radiation, it preserves all future treatment pathways — one of its most important advantages over radiation-based approaches.
How is follow-up managed after focal therapy?
Active follow-up is essential. This typically involves serial PSA testing every 3–6 months and a follow-up mpMRI and/or biopsy at 6–12 months post-treatment. Dr. Bienvenu will outline a specific surveillance protocol based on your pathology and treatment findings.
Does insurance cover HIFU and NanoKnife?
Coverage varies by plan and diagnosis. HIFU has established Medicare coverage; commercial insurance coverage is plan-specific and often requires prior authorization. NanoKnife coverage is more variable. We verify your specific plan before scheduling any procedure and will help navigate the authorization process. Please do not let insurance uncertainty prevent you from scheduling a consultation.
Can I come for a consultation if I've already been treated elsewhere?
Yes. We regularly see patients treated at other institutions — including those with rising PSA after surgery, radiation, or prior focal therapy elsewhere. Please bring all outside records, imaging, and pathology. Salvage focal therapy is a specific area of expertise in our program.
Where are consultations and procedures performed?
All focal therapy consultations and procedures are performed at the University of Tennessee Medical Center in Knoxville (1924 Alcoa Highway, Building B, Suite 222, Knoxville TN 37920), with dedicated procedure days available.
How do I get started?
Message us through Klara, call (865) 305-9254, or ask your referring provider to send a referral to University Urology. Outside biopsy pathology and prior prostate MRI are required before a focal therapy consultation can be finalized — please begin gathering those records as soon as possible.

Ready to Explore Focal Therapy?

Schedule a consultation with Dr. Bienvenu at UT Medical Center in Knoxville. Bring your pathology, MRI, and PSA history — and we'll give you a straight answer about whether focal therapy is right for you.