TULSA Prostate Cancer Ablation: What a 650-Patient Meta-Analysis Shows

A new meta-analysis of TULSA (MRI-guided transurethral ultrasound ablation) for prostate cancer — an ultrasound treatment delivered from inside the urethra while MRI maps tissue temperature in real time — pooled 13 studies and 650 patients. It was published on September 9, 2026 in CardioVascular and Interventional Radiology (CVIR).

In men treated for the first time, urinary continence was preserved in 97%, and major (grade 3 or higher) complications occurred in 2%. However, biochemical recurrence (rising PSA) was 13% and clinically significant cancer on follow-up biopsy 22%. With a maximum follow-up of 36 months, the authors say cancer-control results need "careful contextualisation".

What is new: a meta-analysis of 13 studies and 650 patients

In TULSA, the patient lies inside an MRI scanner and a rod-shaped ultrasound applicator is placed in the urethra. The prostate is heated from the inside outward. Every few seconds MRI produces a temperature map, so the team can confirm that heat reached the planned area and adjust the power. A cooling device in the rectum protects nearby tissue. Because there is no incision and treatment is guided by imaging, it belongs to the same family as image-guided local treatments in interventional radiology (IVR).

Researchers at Allama Iqbal Medical College in Pakistan (first author Arsalan Nadeem) searched PubMed, Embase, Scopus, the Cochrane CENTRAL register and ClinicalTrials.gov up to February 2026 and combined 13 studies with 650 patients using random-effects models. A key feature is that each outcome received a separate GRADE certainty rating. Interventional News covered the paper on October 13 under the headline that TULSA "provides excellent functional preservation, yet warrants contextualisation".

Who is it for

The target is localized prostate cancer that has not spread outside the gland. Most patients in the analysis had low-risk or favourable intermediate-risk disease. Results differed sharply between men treated for the first time and men treated for cancer that came back after radiotherapy (salvage).

• First treatment (treatment-naive): the group with the best outcomes. The authors' conclusion is limited to "carefully selected treatment-naive patients".
• Salvage after radiotherapy: continence was preserved much less often, as previously irradiated tissue carries higher risk.
• High-risk disease: almost absent from the data. The authors note recurrence rates would likely be substantially higher in such patients.

The CAPTAIN trial enrolled men with Grade Group 2–3 disease and PSA of 20 ng/mL or less, and excluded large intraprostatic calcifications and tumours more than 3 cm from the urethra. Because the ultrasound spreads outward from the urethra, tumour location and prostate size strongly affect suitability.

Results: urinary and sexual function, complications, recurrence

Comparisons are with patients' own pre-treatment status (or first treatment vs salvage), not head-to-head with another therapy. Figures are taken directly from the abstract of Nadeem A, et al., CVIR 2026.

Urinary function and complication outcomes carry "moderate" certainty. But every outcome about cancer control was rated "very low", because results varied widely between studies (I² 84–87%) and follow-up was short. The authors point out that biochemical recurrence risk usually plateaus only 5–10 years after treatment, so current numbers cannot stand in for long-term results.

The key study behind the analysis is the TACT trial (115 men, whole-gland ablation, 13 centres in North America and Europe). Four-year results presented at the American Urological Association in 2023 showed median PSA 0.9 ng/mL (86% reduction), 85% (94/111) free of Grade Group 2 or higher cancer at 1-year biopsy, 16% (18 men) receiving salvage treatment by 4 years, 94% pad-free and 81% with erections sufficient for penetration. There were no rectal injuries or grade 4+ events; grade 3 events (infection, retention, pain and others) occurred in 8%.

Early CAPTAIN trial results versus surgery

The main weakness of the meta-analysis is the lack of direct comparison with standard treatment. The CAPTAIN trial, randomizing men between TULSA and robotic radical prostatectomy, aims to fill this gap. First results were presented at the European Association of Urology (EAU) congress in March 2026.

2:1 randomization. Based on the congress presentation and news coverage; no peer-reviewed paper yet. The primary 1-year functional and 3-year cancer-control endpoints have not been reported.

Early functional recovery favoured TULSA, but the presenter called these "early results". Function after surgery often improves over time, and no cancer-control data (12-month MRI and biopsy) for the TULSA group have been released yet. The presenting investigator disclosed ties to the device maker.

Where is it available and how is it approved

A 510(k) clearance means the device is "substantially equivalent" to an existing device; it is not an approval proving effectiveness against a specific cancer.

In the US the device is cleared and offered at several hospitals, but insurance coverage and costs vary by hospital and insurer. In Japan the approval status may have changed, so first confirm whether a hospital offers it as standard care, a clinical trial, or self-pay care. Transrectal high-intensity focused ultrasound (HIFU) uses a similar principle but fires from the rectum and usually relies on ultrasound imaging, whereas TULSA works from the urethra under MRI temperature mapping. Basic concepts are explained in our IVR guide and RFA guide.

Limitations and what patients should check

• Mostly observational: most of the 13 studies were not randomized, so patient selection may bias results.
• Short follow-up: 36 months at most. Prostate cancer grows slowly, so 10-year results matter.
• Mainly low-risk patients: almost no data in high-risk disease.
• Retreatment: about 1 in 7 went on to salvage treatment; how much this complicates later surgery or radiotherapy is not yet well documented.

Questions to ask your doctors:

• Based on my Grade Group, PSA and MRI findings, am I a candidate for TULSA? How far is the tumour from the urethra?
• Will the whole gland be treated or only the cancer area? How do recurrence and side effects differ?
• How many procedures has this hospital done, what is the follow-up MRI and biopsy schedule, and what is the plan if cancer returns?
• What are the pros and cons for me compared with surgery, radiotherapy or active surveillance?
• Is it offered here as standard care, a clinical trial or self-pay care?

For consultation preparation see five questions before an RFA consultation, and for reading study numbers see how to check the study stage of overseas papers.

FAQ

Does TULSA avoid urinary incontinence?

Continence was preserved in 97% of men treated for the first time — high, but not 100%. In salvage treatment after radiotherapy it fell to 47%. Which group you belong to matters most.

Does it lead to less recurrence than surgery?

That is not yet known. The CAPTAIN trial comparing it with surgery has reported only 6-month functional results, and cancer-control results are pending. Recurrence-related outcomes in the meta-analysis had "very low" certainty.

Is it the same as HIFU?

Both use ultrasound heat, but conventional HIFU is delivered from the rectum, while TULSA is delivered from the urethra with real-time MRI temperature monitoring. Devices, eligibility and evidence differ, so they should not be treated as the same therapy.

Can I receive TULSA in Japan?

As of the company's 2019 announcement it was unapproved in Japan, and a hospital introduced it through the expanded-access route. Current approval status, type of care and costs must be confirmed directly with the hospital.

This article summarizes published papers and public materials as general information, not medical advice. Discuss treatment choices with doctors who have examined the patient.