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ACTIVE SURVEILLANCE IN PATIENTS WITH LOW RISK PROSTATE CANCER USING A 20-CORE SATURATION BIOPSY TECHNIQUE
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ACTIVE SURVEILLANCE IN PATIENTS WITH LOW RISK PROSTATE CANCER USING A 20-CORE SATURATION BIOPSY TECHNIQUE
Ignacio F. San Francisco, MD1, Glenn Bubley, MD2, Meredith M. Regan, ScD3, William C. DeWolf, MD2.
1Catholic University School of Medicine, Santiago, Chile, 2Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA, 3Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Background:
Active surveillance treatment for low risk prostate cancer is a viable conservative option for this group of patients. However, there are no validated criteria for correctly placing patients in a protocol of active surveillance. We present the result of our prospective study cohort of active surveillance in patients with low risk prostate cancer using a 20-core saturation biopsy technique . We assessed the predictors of progression on needle biopsies and hypothesize that using saturation 20-core technique, deferred therapy is safe for patients with low grade, low volume prostate cancer.
Methods:
Eighty three consecutive patients were enrolled in a prospective protocol of delayed curative “active surveillance” treatment for low risk prostate cancer beginning on January 1st, 2003, as seen by one urologist (WCD). We analyzed their clinical data and pathology reports. All of the patients were followed with a 20 core- biopsy technique. The inclusion criteria were: clinically localized cancer (T1c-T2), less than 3 positive cores, Gleason score of 6 or less, no more than 50% of a core involved with cancer. The criteria for progression were: ≥ 3 positive cores, increase in grade (Gleason score ≥ 7), and ≥ than 50% of any core involved with cancer. Patients were monitored with an office visit every 6 months and restaging 20 core saturation biopsy every 12-18 months. Definitive treatment as RRP or Radiotherapy was performed in patients who progressed.
Results:
From the 83 patients who fit the entering criteria, 2 withdrew from the protocol before an endpoint was reached and decide to receive RRP or radiation therapy. Therefore, 81 patients were finally analyzed. The mean age of the study group at the time of the first biopsy was 63 years. The median time of follow-up was 26 months. The median number of sets of biopsies was 2. The median PSA, PSA density and PSA velocity before the first biopsy were, 3.7 ng/ml, 0.08 ng/ml/cc and 0.425 ng/ml/year. Eighty percent (65 patients) of the patients had at least 2 sets of biopsies performed, 13/81 (16%) of the patients progressed according to the criteria or 13/65 (20%) of the evaluable patients (i.e. at least 2 biopsies) progressed. Interestingly 36/65 (55%) had a completely negative second biopsy. PSA density was the only predictor of progression when compared with the non-progression group. Of the patients who progressed, 6 underwent radiotherapy and 7 underwent RRP. Of these 7 patients, all had organ confined disease with negative margins and only 3 of them had Gleason scores > 6.
Conclusions:
In our study PSA density is a predictor of progression in univariate analysis. Most of the progressions were at the first re-biopsy and most of the first re-biopsies had no cancer (55%). It is therefore possible that a negative first re-biopsy may be a predictor of non-progression. The patients who progressed and underwent RRP had a final pathology with organ-confined disease. In our setting AS with delayed intervention appears to be a safe and viable option in selected men with low risk prostate cancer.
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