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HIFU as a salvage treatment option after radical prostatectomy

Posted Mar 05 2011 12:00am


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.
  • 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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