Focal One Robotic HIFU for Prostate Cancer Treatment

PRESENTATION SUMMARY

Introduction and Screening

Dr. Ali Afshar from Cedar Sinai Medical Center and Providence St. John's Hospital presented on Focal One robotic focal high-intensity ultrasound therapy for prostate cancer ablation. He emphasized that PSA screening alone is insufficient for diagnosis - velocity and trends matter more than absolute values. Free PSA percentage above 25% suggests lower cancer probability. Combining MRI with urine tests like XODX can help avoid approximately 42% of unnecessary biopsies.

Diagnosis and Biopsy Approach

Dr. Afshar uses MRI fusion transperineal biopsy under sedation, which achieves greater than 90% detection rate for high-risk cancer. This approach offers lower infection risk than transrectal biopsy and better access to anterior prostate regions. The procedure allows for more cores and more comprehensive sampling than traditional methods.

Treatment Options and Focal Therapy

Traditional treatments include active surveillance, radical prostatectomy, and radiation therapy, all with significant data supporting their effectiveness but also substantial side effects. Focal therapy bridges the gap for intermediate-risk patients who want to avoid the major side effects of definitive treatments. The ideal candidates have Gleason 3+4 to 4+3 cancer, unilateral disease, prostate under 50 grams, and minimal calcifications.

HIFU Technology Mechanism

High-intensity focused ultrasound works like a magnifying glass concentrating sunlight, using focused ultrasound waves to heat tissue to at least 55 degrees Celsius for thermal ablation. The Focal One device uses transrectal approach with cooling protection for the rectum, and features 3D imaging by fusing MRI with high-quality ultrasound for precise targeting.

Procedure Details

This is a same-day outpatient procedure with no incisions performed under general anesthesia. Patients receive a catheter for 7-14 days post-procedure and are started on tamsulosin and Cialis for urinary and erectile function support. The procedure includes five days of antibiotics and bladder relaxants if needed for catheter discomfort.

Clinical Evidence

A December 2024 European study across 46 centers compared nearly 2,000 HIFU patients with 1,400 radical prostatectomy patients over 30 months. Cancer-free survival was 90% for HIFU versus 86% for surgery, with superior preservation of urinary continence and erectile function. Another study showed 84% treatment-free survival at 5 years for 25% of patients who received focal therapy.

Advantages of HIFU

The procedure is non-invasive with no scars or radiation exposure, minimal blood loss, and preserves continence and erectile function better than surgery or radiation. Patients can return to work quickly, sometimes within two days. Importantly, it doesn't "burn bridges" - if recurrence occurs, patients can repeat HIFU, undergo surgery, or receive radiation therapy.

Side Effects Profile

Reported complications include 21% average risk of erectile dysfunction, 2.4-6% urethral stricture risk, 1.3% urinary incontinence risk, and 20-25% recurrence rate depending on cancer aggressiveness and patient selection. These rates are significantly lower than radical prostatectomy or radiation therapy complications.

Post-Treatment Monitoring

Patients are monitored with PSA tests every 3 months during the first year, with expected 70-80% PSA drop at 3 months indicating successful treatment. At one year, patients receive an MRI and biopsy to assess for recurrence. Surveillance continues for at least 5 years, with visits every 6 months after year 3.

Patient Case Example

Dr. Afshar presented a young patient with Gleason 4+3 (unfavorable intermediate-risk) whose PSA dropped from 8 to 2.5 after 12 months post-HIFU. The patient maintained 10/10 erectile function, complete continence, improved urinary symptoms, and showed negative MRI at 6 months with a clear ablation defect.

Q&A SESSION SUMMARY

Institutional Adoption

Multiple Los Angeles institutions including Cedar Sinai, Providence St. John's, UCLA, and USC now offer focal therapy. While HIFU is FDA-approved and covered by Medicare, private insurance requires pre-authorization, though Dr. Afshar reports success obtaining approval even from difficult insurers.

Success and Recurrence Rates

One Australian study showed recurrence as low as 7% when treating the same area twice. Overall lifetime recurrence ranges from 20-30% depending on cancer grade, volume, and patient selection. Proper patient selection is critical for optimal outcomes.

Alternative Focal Therapies

While HIFU has the most robust data among focal therapies, other options like cryotherapy or nanoknife may be preferable for certain cases - particularly anterior tumors near the urethra where thermal ablation carries higher urethral stricture risk, or patients with significant prostatic calcifications.

Post-Prostatectomy Recurrence

HIFU can potentially treat recurrence after radical prostatectomy, though it carries higher risks including urethral strictures and must be carefully evaluated based on proximity to rectum (requiring at least 1 cm distance) and ureters. However, radiation therapy plus androgen deprivation therapy remains the guideline-recommended approach with more robust data.

Bilateral Disease

The ideal candidate has unilateral cancer. For bilateral disease, treatment approach depends on the contralateral cancer grade. For example, if one side is Gleason 4+3 and the other is 3+3, treating only the higher-grade side preserves erectile function while monitoring the lower-risk cancer. Treating both sides increases side effect risks but can be discussed based on patient preference.

Salvage Therapy After Radiation

HIFU is an accepted salvage treatment for radiation therapy recurrence when cancer location is identified through PSMA scan, MRI, and biopsy. This can potentially help patients avoid or discontinue androgen deprivation therapy, which causes significant quality of life issues including fatigue, loss of libido, erectile dysfunction, osteoporosis, depression, and cardiovascular risks.

Active Surveillance Considerations

For Gleason 3+3 (low-risk) cancer, active surveillance remains the preferred option as these cancers are unlikely to cause mortality with proper monitoring. Genetic testing like Decipher can provide additional prognostic information about metastatic risk and help guide surveillance decisions. Low Decipher scores (below 0.30) indicate very low probability of disease advancement over 10 years, though continued monitoring remains essential.