What is unique about TULSA-PRO^® ?

• the treatment is incision-free, and is delivered from a catheter inserted in the urethra
• the treatment is performed in a diagnostic MRI, which provides 3D imaging of the tumor and real-time monitoring of the treatment
• the treatment is robotically controlled, and uses the imaging information to ablate a region of the gland with a precision of 1-2mm
• the treatment only takes about 3 hours and is a single session outpatient procedure
• the treatment is highly customizable, and can target the whole gland or regions where there is presence of cancer
• the complication rates for urinary, sexual, or rectal function are much lower with TULSA than all the other options for treating prostate disease

Is there clinical evidence supporting TULSA?

• TULSA received 510k-FDA clearance in 2019 after the completion of the TACT pivotal trial, conducted across 3 countries (Canada, Germany and the USA).
• 115 men enrolled in the study and had their whole prostate gland treated with TULSA.
• The median PSA reduction was 95% (0.34 ng/ml nadir)
• 0% of men had rectal injury
• 1% of men had urinary incontinence
• 3% of men had urethral strictures
• 75% of men preserved their erectile function
• The clinical data supports the effectiveness of TULSA comparable to other treatment options, however with a much greater safety profile

• TULSA is suitable for organ-confined prostate cancer
• Any stage of disease can be treated, however, the largest group of patients treated with TULSA have low- to intermediate- risk cancer with no evidence of disease outside the gland
• TULSA can also be used in the case of recurrent disease, as a salvage treatment option

Enlarged Prostate

• TULSA is suitable for most men with enlarged prostate as long as they do not have contra-indications

What are the contra-indications for TULSA?

• Patients must be able to go inside an MRI scanner
• Patients must be able to tolerate anesthesia for 3h
• Patients cannot have calcifications in the prostate gland >5mm (confirmed with a CT scan) in the region being targeted for ablation
• Patients must not have a prostate greater than 6cm in diameter

How does this compare with the other options I can offer my patients?

• The common treatment options for organ-confined prostate cancer are surgery (radical prostatectomy) or radiation therapy. Compared to these options, TULSA has similar treatment outcomes with 3 year follow-up data. The procedure time is much faster, as is the recovery time. However, the main difference with TULSA is the much lower complication rates for urinary, rectal, and sexual function. The table below summarizes these differences: