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Compare: TULSA-PRO and Other Focal Therapies for Prostate Cancer

Lindsey Flores

It is late, and you have a dozen browser tabs open.

Somewhere between your diagnosis and tonight, the vocabulary changed.

Surgery and radiation, you understood. Now you are reading HIFU, FLA, IRE and TULSA-PRO, and each one says it treats cancer while protecting what you want to keep.

None of them explains how it differs from the others.

This post is meant to be that explanation. We describe each approach plainly, cite the published studies behind the numbers, and include where the alternatives have real strengths. One disclosure first: Integrative Urology offers TULSA-PRO, so that is the option we can speak to most directly. For the others, we are describing mechanism and published results, not ranking them.

The short answer

TULSA-PRO, HIFU, focal laser ablation, cryoablation and irreversible electroporation (IRE) are all energy-based ablation therapies. They destroy prostate tissue in place rather than removing the gland. They differ in the type of energy (sound, laser, cold or electrical pulses), how it reaches the prostate, and what guides the treatment. Which one fits depends on your tumor's location, grade and size, your prostate anatomy and your priorities. A specialist needs to review your MRI and biopsy to say.

What do these therapies have in common?

Each one aims to destroy cancerous tissue while sparing the urethra, nerves and sphincter that affect urinary control and sexual function. Some are used to treat only the area of cancer (focal therapy). Others can treat the whole gland. Several can do either, depending on the device and the treatment plan.

How does TULSA-PRO work, and what did its pivotal trial show?

TULSA-PRO (Transurethral Ultrasound Ablation) works from the inside out. A slim ultrasound applicator placed in the urethra delivers directional heat outward into the prostate while you lie in an MRI scanner. Closed-loop MRI thermometry reads tissue temperature in real time, and the system adjusts treatment parameters to match the plan. An endorectal cooling device helps protect the rectum [1]. TULSA-PRO received FDA 510(k) clearance in August 2019 [2].

The pivotal TACT trial enrolled 115 men with low- to intermediate-risk, organ-confined prostate cancer at 13 sites in five countries. Each man received a single whole-gland treatment that spared the prostatic urethra and urinary sphincter [1][5]. At 12 months:

Study snapshot

TACT pivotal trial: results at 12 months

  • 96% (110 of 115) had a PSA reduction of 75% or more [3].
  • 79% of 68 men with intermediate-risk cancer had no Grade Group 2 or higher disease on the 12-month biopsy [1].
  • 99.1% (111 of 112) preserved urinary continence, defined as no more than one pad a day [3].
  • 75% (69 of 92) of previously potent men kept erections sufficient for penetration [4].
  • 7% had a serious (Grade 3) adverse event, and all resolved [3].

At five years, as presented at the 2023 Society of Urologic Oncology meeting [5]

  • 85% biochemical recurrence-free survival.
  • 22% of men (25 of 115) had received salvage treatment.
  • 92% were pad-free.

These numbers describe a study population, not what any one man should expect.

How does HIFU compare?

High-intensity focused ultrasound (HIFU) also uses sound waves to heat and destroy tissue. The difference is the route. HIFU is typically delivered through the rectum, so the energy passes through the rectal wall to reach the prostate.

Study snapshot

UK multicentre study: 625 men treated with focal HIFU, median follow-up 56 months [6]

Failure-free survival meant freedom from radical or systemic therapy, metastases and cancer-specific death.

  • 99% failure-free survival at one year.
  • 92% failure-free survival at three years.
  • 88% failure-free survival at five years.
  • 98% metastasis-free survival at five years.
  • 98% (241 of 247) of men who returned questionnaires were completely pad-free.
Study snapshot

HIFI study: 3,328 men chose whole-gland or subtotal HIFU or radical prostatectomy [7]

  • 90% of the HIFU group remained free from salvage treatment at 30 months.
  • 86% of the prostatectomy group remained free from salvage treatment at 30 months.

The authors noted that the groups were not randomized and differed in age.

Three HIFU systems are FDA-cleared for prostate tissue ablation: Sonablate 450 (2015), Ablatherm (2015) and Focal One (2018) [8].

How does focal laser ablation compare?

Focal laser ablation (FLA) uses a thin laser fiber placed into the prostate to heat a specific tumor. Like TULSA-PRO, it can be performed under MRI guidance. The energy source is light rather than sound, and it is generally used for a small, well-defined area.

Study snapshot

Single-center series: 120 men with low- to intermediate-risk disease, one-year follow-up [9]

  • 83% were free from retreatment at one year.
  • 17% (20 of 120) needed re-ablation or another treatment after an abnormal follow-up MRI or PSA and a confirming biopsy.

Sexual function (SHIM) and urinary symptom (IPSS) scores did not change significantly.

How does cryoablation compare?

Cryoablation uses thin probes that deliver extremely cold gas to freeze and destroy tissue. It works by cold rather than heat, and it can be used for a focal area or the whole gland.

Study snapshot

UK registry: 122 men with focal cryotherapy (71% intermediate-risk, 29% NCCN high-risk), median follow-up 27.8 months [10]

  • 90.5% failure-free survival at three years.
  • 0 of 69 men reported any pad use at last follow-up.
  • 5 of 31 (16.1%) reported erections insufficient for penetration at last follow-up.

Both functional figures come from the men who returned questionnaires, which is a smaller group than the full registry.

How does irreversible electroporation compare?

IRE delivers short, high-voltage electrical pulses between electrodes placed around a tumor. The pulses damage cell membranes and cause cell death. IRE is non-thermal, so its effect on tissue near neighboring structures works differently from heat- or cold-based methods.

Study snapshot

PRESERVE trial: 121 men with intermediate-risk cancer treated at 17 U.S. centers [11]

  • 71% (95% CI 62% to 79%) had a negative biopsy in the treated area at 12 months.

The FDA cleared the NanoKnife System in December 2024 based on those findings [12]. Clinical experience with IRE in the prostate is more recent than with HIFU or cryoablation.

How do they compare side by side?

The five therapies differ most in energy source and route. Specific devices and techniques vary by provider.

Energy source, route, tissue effect and guidance for five ablation therapies
Therapy Energy Typical route Tissue effect Guidance
TULSA-PRO Directional ultrasound Through the urethra Heat Real-time MRI temperature monitoring
HIFU Focused ultrasound Through the rectum Heat Ultrasound, commonly with MRI-based planning
Focal laser ablation Laser light Fiber through the perineum* Heat Often MRI
Cryoablation Extreme cold Probes through the perineum* Freezing Typically ultrasound
IRE Electrical pulses Electrodes through the perineum* Non-thermal Typically ultrasound

*The perineum is the skin between the scrotum and the rectum.

How do you decide which option fits?

The energy source matters less than whether the treatment fits your specific cancer. These are the questions your care team should be able to answer:

  • Where is the tumor, and how large is it? How does it sit relative to the urethra and the nerve bundles?
  • What is the grade of the cancer, and has it been confirmed by MRI-targeted biopsy?
  • Does your prostate size or anatomy favor one delivery route over another?
  • Are you looking to treat one area or the whole gland?
  • What is the follow-up plan, and what happens if cancer is found again?
  • How many procedures has this physician performed with this specific device?

What does the evidence show, and what does it not show?

What each study measured, and for how long
Therapy Study What it measured Follow-up
TULSA-PRO TACT [1][5] PSA reduction, biopsy result, biochemical recurrence-free survival 12 months and 5 years
HIFU UK multicentre study [6] Failure-free survival: no radical or systemic therapy, metastases or cancer death Median 56 months
HIFU HIFI [7] Salvage-treatment-free survival, compared with prostatectomy 30 months
Focal laser Single-center series [9] Freedom from retreatment 1 year
Cryoablation UK registry [10] Failure-free survival Median 27.8 months
IRE PRESERVE [11] Negative biopsy in the treated area 12 months

Every ablation therapy carries risks. Some men have temporary urinary symptoms, and some have changes in erectile function or continence. In some men the cancer remains or returns and needs further treatment. About 22% of TACT participants had received salvage treatment by five years [5]. Ask each provider what follow-up looks like and what the next step would be if cancer is found again.

Ablation data are also shorter-term than the decades of data behind surgery and radiation. A randomized trial comparing TULSA with radical prostatectomy, called CAPTAIN, is underway [13]. Until results like that are available, ask any provider for the published data on the specific device they use and the type of patient studied.

Does focal therapy only "stun" the cancer?

What you may have read

Focal therapy only stuns the cancer, so it is likely to come back.

What the evidence shows

No. Ablation is designed to kill tissue, not to pause it.

Heat-based methods cause coagulative necrosis, cold destroys cells by freezing, and IRE breaks down cell membranes. When men have had the prostate removed after ablation, pathologists have examined the treated zone directly:

  • In treat-and-resect studies of MRI-guided ultrasound ablation, including TULSA, histology showed no viable cancer within the ablated targets [17].
  • In an ablate-and-resect study of IRE in 16 men, the treated zones showed fibrosis, necrosis and loss of epithelial tissue, and no viable tissue was seen inside them [18].

Two real findings help explain where the "stun" idea can come from. The first is thermofixation. When tissue heats very fast and very high, cells can keep their shape and look alive under a standard stain even though they are not. In a six-man TULSA treat-and-resect study, one man had a region inside the ablation zone that looked viable on standard staining. Special staining showed changes consistent with thermofixation instead, and the authors noted that this can cause treatment failure to be misinterpreted [16]. The second is the edge of the treated zone. In an early study of 14 men treated with HIFU before surgery, complete necrosis was seen in the treated region in every case. Along the back border, however, destruction was incomplete, and four men had a small viable tumor focus there [19]. That is a targeting and margin problem at the edge, not cells being stunned in the middle.

Why does recurrence happen, then?

Recurrence after focal therapy is real, and it comes in two forms:

  • In-field recurrence means cancer returns within or at the edge of the treated zone. This signals that the tumor was not fully treated, and it is typically attributed to targeting imprecision, inadequate energy delivery or insufficient safety margins [20][21].
  • Out-of-field recurrence means cancer is found elsewhere in the gland. Prostate cancer is often multifocal, and small foci can be invisible on MRI or missed on biopsy [20].

One review reports in-field recurrence in roughly 8.5% to 17% of men and out-of-field recurrence in roughly 8.0% to 12.3% [20]. Those figures vary by technology, tumor and study.

What happens after treatment?

Follow-up is part of the treatment. PSA is less reliable after focal therapy because the untreated part of the gland still makes PSA. An international consensus prefers multiparametric MRI to check treatment response, and multiple guidelines advocate protocol biopsies of the treated zone [21]. If cancer is found, options include retreatment or other therapy. In TACT, about 22% of men had received salvage treatment by five years [5]. Before you begin any focal therapy, ask what the follow-up schedule is and what the next step would be.

What about cost and insurance?

Coverage varies by therapy, device, site of service and plan, and it changes over time. Some payer policies still classify focal ablation as investigational, for example the Federal Employee Program's 2025 medical policy [8]. For TULSA, Category I CPT codes took effect on January 1, 2025, and CMS set Medicare payment rates for the procedure [14]. Whether a specific plan covers a specific procedure at a specific facility is a question for your insurer.

Where does Dr. Hong fit in?

Frequently asked questions

Are focal therapy and whole-gland therapy the same thing?

No. Focal therapy treats only the area of cancer. Whole-gland therapy treats the entire prostate. Several ablation technologies can be planned either way, depending on your imaging and biopsy. In the TACT trial, every man received a whole-gland treatment [1][5].

Which option has the fewest side effects?

No trial has compared these ablation therapies head to head, so the honest answer is that it depends on the tumor, the technology and the individual. Ask each provider for the published outcomes for their device and for men with a cancer like yours.

Do these treatments replace surgery or radiation?

No. They are additional options. Surgery and radiation remain appropriate for many men and have long track records. Your specialist can explain where each one fits.

Can I have more treatment if cancer returns?

It depends on the therapy used and your situation. In TACT, about 22% of men had received salvage treatment by five years [5]. Ask about retreatment and follow-up options before you begin, whichever treatment you choose.

Does focal therapy only "stun" the cancer?

No. Ablation is designed to destroy tissue, and treat-and-resect studies found no viable cancer inside well-treated zones [17][18]. Cancer that returns after focal therapy is either in-field, meaning the tumor was not fully treated, or out-of-field, meaning cancer was elsewhere in the gland [20]. Follow-up MRI and biopsy exist to catch both [21].

Is TULSA-PRO covered by insurance?

The procedure at Integrative Urology is self-pay. Category I CPT codes for TULSA took effect in January 2025, and coverage varies by plan and facility [14]. Coverage for other ablation therapies also varies, so verify with your plan.

Bring your questions

Learning the differences between these options is a reasonable thing to do slowly. When you are ready, bring your MRI, your biopsy report and your questions. Bring your spouse or partner too if you would like. The goal of a first conversation is for you to understand your options, whichever path you choose.

Request a consultation

References

Numbers in this post come from the sources below, checked as of September 21, 2026.

  1. Klotz L, Pavlovich CP, Chin J, et al. Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate cancer. J Urol. 2021;205(3):769-779. doi:10.1097/JU.0000000000001362
  2. Profound Medical Corp. News release: Profound Medical receives U.S. FDA 510(k) clearance for TULSA-PRO. August 16, 2019.
  3. Focused Ultrasound Foundation. Prostate cancer trial results announced (final TACT results presented at the AUA annual meeting, May 2019).
  4. Profound Medical Corp. Positive topline results from TACT pivotal clinical trial of TULSA-PRO. April 4, 2019.
  5. Eggener S, Pavlovich C, Koch M, et al. Pivotal study of MRI-guided transurethral ultrasound ablation (TULSA) of localized prostate cancer: 5-year follow up. Society of Urologic Oncology Annual Meeting, November 28 to December 1, 2023. Abstract.
  6. Guillaumier S, Peters M, Arya M, et al. A multicentre study of 5-year outcomes following focal therapy in treating clinically significant nonmetastatic prostate cancer. Eur Urol. 2018;74(4):422-429. doi:10.1016/j.eururo.2018.06.006
  7. Ploussard G, Coloby P, Chevallier T, et al. Whole-gland or subtotal high-intensity focused ultrasound versus radical prostatectomy: the prospective, noninferiority, nonrandomized HIFI trial. Eur Urol. 2025;87(5):526-533. doi:10.1016/j.eururo.2024.11.006. Figures as summarized by Urology Times.
  8. Blue Cross and Blue Shield Federal Employee Program. Medical Policy 8.01.61: Focal Treatments for Prostate Cancer. January 2025. Also the source for FDA clearance dates of Sonablate 450, Ablatherm and Focal One.
  9. Walser E, Nance A, Ynalvez L, et al. Focal laser ablation of prostate cancer: results in 120 patients with low- to intermediate-risk disease. J Vasc Interv Radiol. 2019;30(3):401-409.e2. doi:10.1016/j.jvir.2018.09.016
  10. Shah TT, Peters M, Eldred-Evans D, et al. Early-medium-term outcomes of primary focal cryotherapy to treat nonmetastatic clinically significant prostate cancer from a prospective multicentre registry. Eur Urol. 2019;76(1):98-105. doi:10.1016/j.eururo.2018.12.030
  11. George AK, Miocinovic R, Patel AR, et al. Irreversible electroporation for prostate tissue ablation in patients with intermediate-risk prostate cancer: results from the PRESERVE trial. Eur Urol. 2025. PubMed 40685282
  12. Urology Times. Irreversible electroporation with NanoKnife found safe, effective for prostate tissue ablation. Reports FDA 510(k) clearance of the NanoKnife System in December 2024.
  13. Urology Times. TULSA compared with radical prostatectomy in phase 3 trial. Describes the CAPTAIN trial design.
  14. Profound Medical Corp. TULSA reimbursement raised to Urology APC Level 7 under CMS OPPS final rule for CY2025. November 4, 2024.
  15. Profound Medical Corp. Press release on Dr. Y. Mark Hong's 200th independent TULSA-PRO procedure. November 2025.
  16. Anttinen M, Yli-Pietilä E, Suomi V, et al. Histopathological evaluation of prostate specimens after thermal ablation may be confounded by the presence of thermally-fixed cells. Int J Hyperthermia. 2019;36(1):915-925. doi:10.1080/02656736.2019.1652773
  17. Magnetic resonance imaging-guided ultrasound ablation for prostate cancer: a contemporary review of performance. Front Oncol. 2022;12:1069518. doi:10.3389/fonc.2022.1069518
  18. Histopathological outcomes after irreversible electroporation for prostate cancer: results of an ablate and resect study. PubMed 27004693
  19. Transrectal high-intensity focused ultrasound using the Ablatherm device in the treatment of localized prostate carcinoma. PubMed 10443724
  20. Patient and technology selection for focal therapy in prostate cancer. PMC13359799
  21. Multiparametric MRI before and after focal therapy for prostate cancer: pearls and pitfalls for the reporting radiologist. Radiology: Imaging Cancer. doi:10.1148/rycan.240269

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