The TULSA Procedure is a minimally invasive procedure that uses magnetic resonance (MR) imaging-guided transurethral ultrasound to ablate prostate tissue. This procedure is customizable, predictable, incision-free, and has been shown in a multi-national phase 1 study (30 patients)¹ and a subsequent Pivotal study (115 patients)² to be feasible, safe and a well-tolerated option for localized prostate cancer.

While the phase 1 trial followed a conservative treatment plan, the Pivotal study (called TACT, or TULSA-PRO Ablation Clinical Trial) protocol was designed to achieve whole-gland ablation with urethra and apical sphincter sparing.  During the TACT trial, 20% of patients had a biopsy with residual clinically significant prostate cancer, and 7% of patients were retreated by 2 years after their TULSA Procedure (salvage treatment). These rates are comparable with accepted rates of early failure or additional intervention after standard treatments ^{(4, 5)} and retreatment goals after ablative therapies ⁶. In other words, the chance of the TULSA Procedure failing is similar to the chance of failure from other prostate ablative therapies like radiation and prostatectomy.

It is important to know that choosing the TULSA Procedure does not limit post-procedure options.  In cases where further prostate care is needed, or if the TULSA Procedure is not successful, patients have the flexibility to have a repeat TULSA Procedure, or to choose from any other prostate therapies to address their prostate needs. In other words, the TULSA Procedure does not “burn bridges”.

Salvage Prostatectomy after TULSA Procedure

If a patient has undergone the TULSA Procedure, they are still able to undergo other prostate interventions should they be required. Radiation therapy, radical prostatectomy, and transurethral resection of the prostate (TURP) are all examples of other prostate interventions that are not contraindicated by a previous TULSA Procedure.

In a study by Nair et al., four patients with residual cancer following the TULSA Procedure underwent open radical prostatectomy (surgery) within 39 months of the TULSA Procedure. After a median follow-up of 34 months after surgery, two patients with negative surgical margins continued to have a low PSA, while the other two patients eventually experienced a PSA rise and underwent additional treatment with radiation and/or hormone therapy. None of the patients developed metastatic disease. Erectile dysfunction after prostatectomy responded well to pharmacologic treatment³.

There were no complications that occurred during the surgery, and it was observed that fibrosis after the TULSA Procedure was less extensive than usually seen after radiation therapy. There were no cases of lymph node metastasis, and all patients were able to have unilateral nerve sparing surgery. Oncological, safety, and functional outcomes shown for salvage prostatectomy after the TULSA Procedure were comparable with salvage performed post-radiation therapy. In addition, there were no instances of anastomotic stricture of rectal injury, nor major complications that may be encountered in post-radiation salvage³.

Although this study reported on a small number of patients treated by a single surgeon, these findings illustrate that salvage prostatectomy after the TULSA Procedure is a viable and safe option. “Technical difficulty and perioperative morbidity were negligible and attributable to minimal peri-prostatic reaction from the TULSA Procedure” ³.

Conclusion

The TULSA Procedure is repeatable – meaning it can be performed more than once, and it does not limit other post-procedure options.  TULSA Procedure is not only designed to be customizable, predictable and incision-free, but it opens doors for patients to have continued prostate care depending on their needs and condition. Instead of “burning bridges” the TULSA Procedure aims to “build bridges” when it comes to patient care.

To learn more about the benefits of the transurethral delivery method and the benefits of having an incision-free procedure such as the TULSA Procedure, visit our ‘About TULSA Procedure‘ page today.

References:

1. Chin, Joseph L., et al. “Magnetic resonance imaging–guided transurethral ultrasound ablation of prostate tissue in patients with localized prostate cancer: a prospective phase 1 clinical trial.” European urology3 (2016): 447-455.

2. Klotz, Laurence et al. “Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Cancer.” The Journal of urology, 101097JU0000000000001362. 6 Oct. 2020, doi:10.1097/JU.0000000000001362

3. Nair, Shiva Madhwan, et al. “Salvage open radical prostatectomy for recurrent prostate cancer following MRI-guided transurethral ultrasound ablation (TULSA) of the prostate: feasibility and efficacy.” Scandinavian journal of urology3 (2020): 215-219.

4. Hamdy FC, et al. “ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cance”r. N Engl J Med. 2016 Oct 13;375(15):1415-1424.

5. Agarwal PK, et al. “Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE). Treatment failure after primary and salvage therapy for prostate cancer: likelihood, patterns of care, and outcomes”. Cancer. 2008 Jan 15;112(2):307-14.

6. Donaldson IA, et al. “Focal therapy: patients, interventions, and outcomes–a report from a consensus meeting”. Eur Urol. 2015 Apr;67