HIFU as a salvage treatment option after radical prostatectomy

The standard form of treatment for a man with a rising PSA after a first-line radical prostatectomy (RP) is salvage radiation therapy (with or without a period of androgen deprivation). However, an Italian group has just published pilot data on the use of high-intensity focused ultrasound (HIFU) as salvage therapy after RP.

Asimakopoulos et al. used HIFU as first-line salvage therapy in a prospective series of 19 men who all had palpable, TRUS-evidenced, biopsy-proven, locally recurrent prostate cancer after radical prostatectomy (RP). These men were all unwilling to undergo salvage radiotherapy (SRT). They were all given HIFU as a single-session procedure with an overnight hospital stay post-HIFU.

Clinical success was defined as PSA nadir ≤ 0.1 ng/ml within 3 months after HIFU. For patients with a PSA nadir > 0.1 ng/ml or a PSA increase ≥ 1 ng/ml above the PSA nadir, a biopsy of the treated lesion was performed. Combined androgen deprivation therapy (ADT2) was given to all men who had a negative biopsy; external beam radiation therapy (EBRT) was performed on men who had a positive biopsy. Failure of salvage HIFU was defined as use of secondary adjuvant treatment (ADT2 or EBRT).

The results of this small pilot study are as follows:

  • Average (median) follow-up was 48 months.
  • No cases of urethrorectal fistula or anastomotic stricture were observed.
  • Two cases of acute urinary retention were effectively managed with prolonged urethral catheterization.
  • Four cases of stress urinary incontinence were observed.
    • 2 cases of mild incontinence resolved within 6 months after pelvic floor exercises.
    • 2 cases of severe incontinence required minimally invasive surgery.
  • 17/19 patients (89.5 percent) had nadir PSA levels of ≤ 0.1 ng/ml and met initial criteria for success.
  • 2/19 patients ( 10.5 percent) failed to show a PSA nadir < 0.1 ng/ml.
  • During follow-up, 8/17 patients (47 percent) progressed and were classified as failures.
  • The overall number of failures at a median 4 years of follow-up was 10/19 (52.6 percent).
  • Higher PSA levels pre-HIFU and higher Gleason scores in the RP specimens appear to increase risk for failure of HIFU as a salvage therapy.

The authors conclude that salvage first-line HIFU is a feasible, minimally invasive, one-day procedure for the treatment of men with palpable, TRUS-evidenced, biopsy-proven local recurrence of prostate cancer, and has an acceptable morbidity profile.

This would appear to be a situation in which a randomized, prospective clinical trial would be feasible to test the effectiveness and safety of salvage HIFU versus salvage EBRT in a group of men with (say) pathologic Gleason scores of ≤ 7 and PSA levels of ≤ 2.0 ng/ml who have recurrent, localized, biopsy-proven prostate cancer after RP.

Salvage HIFU is clearly a more convenient and perhaps a less morbid procedure than salvage EBRT after RP. A prospective, multi-center, randomized clinical trial comparing two groups of patients in the manner suggested above is potentially in the best interests of patients — although the radiation oncology community may be less enthusiastic about such a trial.

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