Defining post-HIFU biochemical treatment failure

An international group of physicians who have been researching the applicability of high-intensity focused ultrasound (HIFU) as a means to treat localized prostate cancer have issued a preliminary guidance document on what constitutes biochemical failure following first-line treatment with HIFU.

The so-called Stuttgart definition, just described by Blana et al., proposes a definition of biochemical failure that is specific to patients treated with HIFU and states that such failure occurs when the patient’s PSA increases beyond the PSA nadir + 1.2 ng/ml. In other words, if a man is treated with HIFU and his PSA drops to a lowest (nadir) level of 0.27 ng/ml after treatment, but then starts to rise again, he will meet the definition of biochemical failure when his PSA exceeds 0.27 +1.2 = 1.47 ng/ml.

This definition has been derived from a careful analysis of data from 285 patients treated consecutively with HIFU between October 1997 and July 2006 at two European centers. Clinical failure among these patients was defined as any one of the following:

  • Positive prostate biopsy after treatment
  • Radiographic evidence of lymphatic or bony metastatic disease
  • Salvage treatment for prostate cancer (surgery, radiation, hormonal therapy or second HIFU).

Serum PSA levels after HIFU were also monitored to provide a biochemical surrogate of a therapeutic success or failure, and six different methods of estimating biochemical failure were evaluated against this database:

  • A specific PSA threshold value
  • A PSA nadir plus value
  • PSA velocity
  • PSA doubling time
  • The American Society or Therapeutic Radiotherapy and Oncology and Phoenix definitions of biochemical failure

All patients were clinical stage ≤ T2, had a PSA value at diagnosis of < 15 ng/ml,  and a Gleason score of  ≤ 7.  The median follow-up period was 4.7 years  (with a range of 2.0-10.9 years) years. The median PSA nadir for all patients was 0.13 ng/ml, which occurred at a median of 12.9 weeks after HIFU, and the median PSA at the last follow-up was 0.76 ng/ml (with a range of 1.6-2.7 ng/ml). Clinical failure occurred in 71 patients (25 percent); 24 due to a positive biopsy and 47 through the use of an additional therapy.

The authors report that the biochemical events that best predicted clinical failure were ‘PSA nadir plus’ values of 1.1-1.3 ng/ml, PSA velocities of < 0.3 ng/ml/year and PSA doubling times of 1.25-1.75 years.

2 Responses

  1. I had HIFU with Dr. S. Scionti some 8 years ago. My PSA is now shooting upwards. I went to see him in Sarasota. He gave me an MRI and a 12-needle biopsy. He said the cancer has returned, but no specifics. I asked to be sent the tests and the results, but I got no answer from him or his nurse, so I wrote and faxed a request, still no answer. He did use the number 7, but didn’t say “Gleason”.

    Is it the law that he send me the results? I hate to doubt him, but his evasion has me worried.

  2. Dear Don:

    You or your insurance provider have paid this physician for the tests that were carried out on you. You are therefore entitled to receive a full report of the results of those tests.

    I can’t tell you exactly what Florida law says is the physician’s legal responsibility in the situation you describe, but you do have the right to receive all of the relevant data, and your best bet might be to get a friendly lawyer to write to the physician on your behalf requesting copies of the MRI scan data and the biopsy report by certified mail within 7 days.

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