For men aged 50‑80 with low‑ to intermediate‑risk localized prostate cancer (Gleason grade ≤7, prostate‑specific antigen ≤10 ng/mL, clinical stage T1‑T2) and prostate volume ≤50 mL, what are the indications, patient selection criteria, procedural details, benefits, risks, and follow‑up recommendations for transurethral ultrasound ablation (TULSA)?

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Last updated: February 26, 2026 • View editorial policy

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Transurethral Ultrasound Ablation (TULSA) for Localized Prostate Cancer

Primary Recommendation

TULSA may be considered for select men with intermediate-risk localized prostate cancer who are appropriately counseled about the lack of high-quality comparative data, with clinical trial enrollment strongly prioritized; it should not be used for low-risk disease (where active surveillance is preferred) or high-risk disease (where it lacks supporting evidence). 1

Patient Selection Criteria

Appropriate Candidates

  • Risk stratification: Intermediate-risk disease only (Gleason 7 OR PSA 10-20 ng/mL OR clinical stage T2b) 1
  • Age range: Men aged 50-80 years with life expectancy >10 years 2
  • Prostate volume: ≤50 mL for optimal technical feasibility 2
  • Disease characteristics: Uni- or multifocal organ-confined carcinoma confirmed by biopsy 2
  • Special consideration: Patients with concurrent symptomatic BPH may benefit from combined therapy 2, 3

Exclusions

  • Low-risk disease (Gleason ≤6, PSA <10 ng/mL, stage T1-T2a): Active surveillance is the preferred approach 1, 4
  • High-risk disease (Gleason 8-10, PSA >20 ng/mL, stage ≥T2c): Whole-gland or focal ablation should not be recommended outside clinical trials 1
  • Life expectancy <10 years: Observation or watchful waiting is more appropriate 1

Procedural Details

Technical Approach

  • MRI guidance: Treatment performed under real-time MRI thermometry for monitoring and control 2, 5
  • Equipment: MRI-compatible transurethrally inserted ultrasound applicator with endorectal cooling device 2
  • Ablation method: Robot-driven rotation of the applicator delivers controlled thermal energy 2
  • Treatment options: Whole-gland ablation (for diffuse disease) or focal ablation (for localized lesions), with neurovascular bundle sparing possible in most cases 2, 3

Preoperative Requirements

  • Imaging: Multiparametric MRI to define tumor location and extent 3
  • Biopsy confirmation: Histopathologically confirmed prostate cancer 2, 3
  • Anesthesia: General anesthesia or spinal anesthesia 5

Benefits

Functional Outcomes

  • Erectile function: Median International Index of Erectile Function score remains stable (24 to 25) over 48 months; potency preserved in previously potent men 2, 3
  • Urinary continence: Pad-free continence preserved in 96% of patients 2
  • Urinary symptoms: International Prostate Symptom Score initially worsens post-treatment but improves to better than baseline over 48 months 2
  • BPH benefit: 83% of patients with concurrent BPH report symptom improvement 3

Oncological Outcomes (Early Data)

  • PSA response: Median PSA nadir 1.1 ng/mL after primary treatment 3
  • Early treatment success: 88% demonstrate negative multiparametric MRI and lack of PSA recurrence at median 14-16 months follow-up 3, 6
  • Histologic benefit: All patients in one series demonstrated histologic benefit at 12-month biopsy 6

Risks and Complications

Safety Profile

  • Grade 1-2 complications: Occur in approximately 19% of patients, resolving within 4 weeks 2
  • Grade 3 adverse events: Occur in approximately 2% of patients, resolving within 3 months 2
  • No Grade 4 or higher events: No bowel-related complications observed 2
  • Perioperative morbidity: Minimal when compared to radical prostatectomy 7

Specific Complications

  • Urinary incontinence: Rare worsening (approximately 4% require ≥1 pad daily) 2
  • Erectile dysfunction: May occur but is generally responsive to treatment 7
  • Urinary obstruction: Temporary worsening of lower urinary tract symptoms post-procedure 2

Follow-Up Recommendations

Surveillance Protocol

  • PSA monitoring: Every 6 months for the first 5 years, then annually 8
  • Imaging: Multiparametric MRI to assess treatment response and detect residual disease 3
  • Biopsy: Performed if PSA rises or MRI shows suspicious findings 2, 3

Biochemical Failure Management

  • Definition: PSA recurrence or positive biopsy findings 2
  • Incidence: Biochemical failure occurs in approximately 8-12% of patients at early follow-up 2, 3
  • Salvage options: Repeat TULSA is feasible; salvage radical prostatectomy is technically viable with minimal additional morbidity 7, 2
  • Salvage therapy rate: Required in approximately 5% of patients 2

Critical Evidence Limitations

Lack of High-Quality Comparative Data

The 2022 AUA/ASTRO guidelines emphasize that patients must be informed about the absence of high-quality data comparing ablation outcomes to radiation therapy, surgery, and active surveillance. 1

  • No properly powered randomized trials: The only randomized trial of focal ablation (photodynamic therapy) was limited to low-risk disease, where active surveillance is preferred 1
  • Insufficient long-term data: Most studies report median follow-up of 14-16 months, inadequate for assessing long-term oncological outcomes 2, 3
  • Clinical heterogeneity: Patient selection criteria and treatment protocols vary widely across studies 1
  • Systematic review conclusions: Multiple systematic reviews conclude there is insufficient high-certainty evidence to make definitive conclusions regarding clinical effectiveness of focal therapy 1

Common Pitfalls and How to Avoid Them

Inappropriate Patient Selection

  • Pitfall: Offering TULSA to low-risk patients who should be on active surveillance 1
  • Avoidance: Strictly adhere to intermediate-risk criteria; counsel low-risk patients that surveillance has equivalent oncological outcomes at 10 years 4

Overestimating Oncological Efficacy

  • Pitfall: Presenting TULSA as equivalent to radical prostatectomy or radiation therapy 1
  • Avoidance: Explicitly inform patients that long-term oncological data are lacking and that standard treatments (surgery, radiation) have decades of proven efficacy 1

Inadequate Pre-Treatment Staging

  • Pitfall: Under-staging disease, leading to incomplete treatment (salvage pathology showed pT3a in 3 of 4 patients in one series) 7
  • Avoidance: Obtain high-quality multiparametric MRI and consider extended biopsy protocols to accurately assess disease extent 3

Failure to Prioritize Clinical Trials

  • Pitfall: Offering TULSA as routine care outside of research protocols 1
  • Avoidance: The AUA/ASTRO guidelines explicitly state that clinical trial enrollment should be prioritized for patients considering ablation 1

Ignoring Salvage Options

  • Pitfall: Not counseling patients that salvage radical prostatectomy remains feasible if TULSA fails 7
  • Avoidance: Inform patients that salvage surgery is technically viable with minimal additional morbidity, providing a safety net 7

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

4
Guideline

Prostate Cancer Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

8
Guideline

Post-Prostatectomy Follow-Up Guidelines

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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