Salvage surgery as second-line therapy after HIFU for localized prostate cancer

High-intensity focused ultrasound (HIFU) is approved in Canada for the treatment of localized prostate cancer. Since its approval, this form of treatment has become popular among patients seeking a potentially curative form of treatment with low risk for complications and side effects.

As the popularity of the technique has grown, however, there has also been an inevitable if gradual growth in the number of men seeking salvage therapy after the failure of whole-gland HIFU.

Lawrentschuk et al. have reported prospectively collected data on a series of 15 men, initially seen between 2007 and 2010, and presenting with a rising PSA and biopsy-proven prostate cancer after first-line treatment with HIFU. All 15 men received an open, salvage radical prostatectomy and were carefully followed over time to assess their subsequent outcomes.

The results of this study (based on careful reading of the entire text of this paper, not just the abstract) are as follows:

  • The average (median) age  of the patients at time of initial diagnosis, pre-HIFU, was 64 years (range, 48 to 74 years).
  • The men had received HIFU treatment with either Sonoblate (n = 8) or Ablatherm (n = 7) equipment.
  • Either 3 or 4 of the 15 men had received at least two HIFU treatments. (This is not clear, even in the full text of the study.) Two patients had also received a single dose of an LHRH agonist in association with their HIFU.
  • Before their treatment with HIFU the patients had
    • A Gleason score of 6 (n = 8), 3 + 4 = 7 (n = 6), or 4 + 3 = 7 (n = 1)
    • An average (median) percentage of  biopsy cores positive for cancer of 39 percent (range, 17 to 63 percent)
    • An average (median) PSA level of 7 ng/ml (range, 5 to 8 ng/ml)
  •  After whole gland HIFU the patients had 
    • An average (median) nadir (minimum) PSA level of 1.1 ng/ml (range, 0.5 to 3.1 ng/ml)
    • A biopsy-based Gleason score of 6 (n = 3), 7 (n = 9), or 8/9 (n = 3)
    • An average (median) percentage of  biopsy cores positive for cancer of 42 percent (range, 25 to 50 percent)
  • Prior to salvage surgery the patients’ average (median) PSA level was 3.8 ng/ml (range, 0.7 to 8.84 ng/ml).
  • The average (median) time from treatment with HIFU to salvage radical prostatectomy was 22 months (range, 7 to 26 months).
  • Despite the fact that the surgeons were all experienced (having carried out at least 500 open radical prostatectomies), the procedure was difficult; nerve-sparing was not possible in any patient.
  • One patient with rectal injury required a transfusion during his surgery.
  • Pathologic finding post-surgery included
    • Extensive fibrosis within the prostate in combination with persistent prostate cancer
    • Stage pT3 disease in 9/14 patients
    • Gleason scores of 6 (n = 2), 3 + 4 = 7 (n = 5), 4 + 3 = 7 (n = 4), and 8/9 (n = 4)
    • Focally positive margins were observed in 4/15 patients (all of whom had stage pT3a disease).
  • Average (median) post-surgical follow-up was 16 months (range, 6 to 24 months).
  • The post-surgical PSA level was < 0.05 ng/ml in 12/14 patients (with biochemical recurrence and further treatment required in 2/14 patients).
  • Postoperative continence (at ≥12 months of follow-up) yielded no pad use in 6/11 men and use of one pad daily (for confidence) but no leakage in 3/11 men; the other 2/11 patients required 2 and 6 pads/day, respectively. Four patients had ≤ 6 months of follow-up.
  • Post-surgical erectile function was universally poor (as a consequence of the inability to perform nerve-sparing surgery).

Lawrentschuk and his colleagues conclude that, “Radical prostatectomy as salvage is feasible” for men with biochemical failure after HIFU. However, the operation has a higher morbidity than first-line surgical treatment for localize disease. The also note that oncologic control appears to be “acceptable” in this series of patients with a relatively high incidence of pT3 disease.

Even though this is a small patient cohort, it is the largest series of salvage surgery patients seen in the published literature to date. The percentage of patients who have required second-line, salvage therapy after HIFU (with surgery or any other form of treatment) is not currently known. All we can really say at this time is that these results should be factored in when counseling men who wish to undergo primary HIFU.

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