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Transurethral Ultrasound Ablation Procedure vs Robotic-Assisted Laparoscopic Radical Prostatectomy

By: Y. Mark Hong, MD, Integrative Urology, Phoenix, Arizona | Posted on: 20 May 2024

Prostate cancer accounts for 29% of male nonskin cancers in the US, with 299,010 new diagnoses and 35,250 deaths in 2024.1 The evolution of radical prostatectomy has reflected the need to balance cancer cure with minimizing debilitating side effects of surgery. Despite advances from open to nerve-sparing to modern robotic prostatectomy, the surgical “trifecta” of cancer cure, urinary continence, and sexual function has remained elusive, giving rise to active surveillance as the standard of care for low-risk prostate cancer. Alternative surgical therapies such as cryotherapy, focal laser ablation, and high-intensity focused ultrasound have been driven by the need to balance cure and quality of life, but concerns for durable cure and safety have limited adoption, especially with focal therapy of a biologically multifocal cancer.


Figure 1. Transurethral ultrasound ablation procedure. A, Rendering of ultrasound applicator and endorectal cooling device. B, Sagittal and coronal views of 3D T2-weighted image of ultrasound applicator and planned ablation zone. C, Ablation zone prescribed on intraoperative axial T2-weighted images from prostate apex to base. D, MRI temperature map depicting maximum temperatures achieved during treatment. E, Enhancement defect confirms ablation extent on posttreatment contrast enhanced T1 weighted images. Reprinted with permission from Klotz et al, J Urol. 2021;205(3):769-779.2
Figure 2. Longitudinal patient-reported health-related quality of life (HRQOL) and satisfaction with cancer outcome after radical prostatectomy, stratified by surgical approach and nerve-sparing (NS) status. A-E, Health domains of EPIC-26 HRQOL instrument.8 F, Satisfaction with cancer outcome, domain of Service Satisfaction Scale for Cancer Care instrument.9 Surgical approach (open radical prostatectomy [ORP] vs robot-assisted laparoscopic prostatectomy [RALP]) was not found to be significant predictor of longitudinal patient-reported HRQOL change in any domain. Reprinted with permission from Chang et al, J Urol. 2022;207:127-136.6

Transurethral ultrasound ablation procedure (TULSA-PRO) is a Food and Drug Administration–approved MRI-guided ultrasound treatment for prostate cancer. TULSA-PRO is an incision-less outpatient surgery utilizing magnetic resonance thermography to guide prostate ultrasound ablation transurethrally, avoiding damage to rectal tissue planes. High-resolution MRI and continuous real-time magnetic resonance feedback allow precise ablative control of key structures including cancerous areas and urinary sphincter and neurovascular bundles. TULSA-PRO is customizable to focal, multifocal, partial-gland, or whole-gland therapy, depending on patient and surgeon collaboration of the treatment plan. TULSA-PRO is thus unique from prostatectomy in that patient input can guide the treatment plan depending on patient-centered goals for continence and erectile function, conceptually as if performing a “partial” vs radical prostatectomy depending on patient wishes (Figure 1).2

Initial data for TULSA-PRO have been promising. The pivotal TACT trial showed 96% of 115 men with intermediate and low-risk prostate cancer experienced a PSA reduction of 75% or more at 12 months follow-up.2 Among 68 men with intermediate-risk cancer, 79% were free of Gleason Group 2 or higher disease at 12-month prostate biopsy per protocol.2 Five-year presented data showed biochemical recurrence-free survival of 85% at 5 years and 5-year overall survival rate of 99%.3 Twenty-five patients (22%) have undergone salvage therapy, including 10 prostatectomy, 11 radiation, 3 androgen deprivation therapy plus radiation, and 1 surgery radiation combined treatment.3 Grade 2 erectile dysfunction was 23% at 1 year and 25% at 5 years, with 87% of men reporting erections sufficient for penetration. Grade 2 urinary incontinence was 3% at 1 year and 2% at 5 years, with 92% pad free at 5 years.3 No rectal injuries or Grade 4 adverse events have been reported to date.4 Others have reported similar findings.5

The question is whether TULSA-PRO can be a feasible alternative to robotic-assisted laparoscopic radical prostatectomy (RALP). While significant improvements have been demonstrated in the open to RALP era, such as blood loss and length of stay, no significant differences have been found in quality of life domains with longitudinal 2-year follow-up for open prostatectomy vs RALP, especially for urinary incontinence and erectile dysfunction (Figure 2).6 Higher decision regret has been shown in patients with worse posttreatment sexual and urinary function after treatment for localized prostate cancer.7 An alternate, nonradiation-based surgery capable of whole-gland therapy such as TULSA-PRO would be appealing for men seeking to treat prostate cancer while preserving quality of life. Pooled data showed 80% potency and 98% continence at 12 to 16 months follow-up after TULSA-PRO.5 Therefore, for men with intermediate-risk prostate cancer who are willing to accept a potentially higher cancer recurrence rate to preserve quality of life, TULSA-PRO may be a reasonable and safe surgical option. TULSA-PRO may also be a feasible alternative to radiation therapy, as recurrence after TULSA-PRO does not typically preclude a man from undergoing salvage surgery or radiation.

Perhaps one lesson learned in the open to robotic era is patient demand can drive adoption faster than the scientific community. There are multiple barriers to adoption that currently limit widespread availability of TULSA-PRO. Equipment cost and lack of uniform insurance coverage are significant factors. Long-term efficacy and safety are being addressed by the TACT trial and CAPTAIN study, an unprecedented head-to-head multicenter randomized controlled trial comparing safety and efficacy of TULSA-PRO to radical prostatectomy, currently accruing. Perhaps most importantly, a steep learning curve will limit adoption due to the fundamental shift from a robotic, incision-based environment to an image-guided, ablative one. Urologists are not typically trained in reading prostate MRI with surgical intent or the unique safety environment of MRI-based surgery such as magnetic field effects. Limited access to an MRI-based surgical suite has led to early adoption of TULSA-PRO by radiologists. Concerns persist regarding technical ownership of nerve-sparing, sphincter preservation and cancer control portions of the procedure intraoperatively, especially if the treating physician and the physician responsible for outcomes and complications postoperatively are not the same. From personal experience performing over 100 TULSA-PRO cases with over half performed at a urologist-led center without radiologists on-site, the need for the responsible surgeon to perform critical aspects of treatment planning and nerve preservation is crucial to achieving optimal oncological and quality of life outcomes, as is the case for RALP.

The question of TULSA-PRO vs RALP for intermediate-risk prostate cancer will be answered with longer-term results and increased numbers treated. With Medicare coverage commencing in 2025, the real question is how urologists will respond to the increase in patient-driven TULSA-PRO demand likely to occur, and whether urologists will retain ownership over and lead the surgical and cancer care experience.

  1. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024;74(1):12-49. doi:10.3322/caac.21820
  2. 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
  3. 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. Poster presented at: Society of Urologic Oncology Annual Meeting; November 28-December 1, 2023; Washington, DC.
  4. Pavlovich C, Eggener S, Koch M, et al. MP73-05 Pivotal study of MRI-guided transurethral ultrasound ablation (TULSA) of localized prostate cancer: 4-year follow up. J Urol. 2023;209(Suppl 4):e1036. doi:10.1097/JU.0000000000003341.05
  5. Dora C, Clarke GM, Frey G, Sella D. Magnetic resonance imaging-guided transurethral ultrasound ablation of prostate cancer: a systematic review. J Endourol. 2022;36(6):841-854. doi: 10.1089/end.2021.0866
  6. Chang P, Wagner AA, Regan MM, et al; PROST-QA/RP2 Consortium. Prospective multicenter comparison of open and robotic radical prostatectomy: the PROST-QA/RP2 consortium. J Urol. 2022;207(1):127-136. doi:10.1097/JU.0000000000002176
  7. Fanshawe JB, Wai-Shun Chan V, Asif A, et al. Decision regret in patients with localized prostate cancer: a systematic review and meta-analysis. Eur Urol Oncol. 2023;6(5):456-466. doi: 10.1016/j.euo.2023.02.005
  8. Szymanski KM, Wei JT, Dunn RL, Sanda MG. Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors. Urology. 2010;76(5):1245-1250. doi:10.1016/j.urology.2010.01.027
  9. Shah NL, Dunn RL, Greenfield TK et al. Development and validation of a novel instrument to measure patient satisfaction in multiple dimensions of urological cancer care quality. J Urol. 2003;169(Suppl 4):11.