Patients and methods used in the study6
From October 1991 to December 1995, 487 patients were randomized in a prospective randomized multicenter trial.27 For inclusion, patients had to have T2-3NxM0 prostate carcinoma, confirmed by histology. PSA had to be below 100. Patients were randomized for direct radical retropubic prostatectomy ('control group') or neoadjuvant hormonal therapy (NHT) using the LHRH analog goserelin (3.6 mg subcutane-ously/month) and flutamide (250 mg trice daily) for a period of 3 months followed by radical retropubic prostatectomy ('NHT group'). At randomization, patients were stratified for clinical T category and pathological grade of the tumor for each participating center. Parameters investigated were: serial PSA levels, pretreatment and post-treatment prostate volumes (TRUS), clinical stage before and after NHT and ease of surgery. All pathologists used the same standardized prostatectomy step-section protocol and all surgical specimens were classified according to the TNM classification (1987 version). Clinical downstaging was defined as a clinical stage after NHT lower than the clinical stage at baseline, and pathological downstaging was defined as a pathological stage after NHT lower than the clinical stage at baseline. Only in pT4, pN2, cM + patients or in patients with postoperative PSA levels >1.0ng/ml on two subsequent occasions were urologists allowed to start postsurgical treatment. The end-points used were the abovementioned postoperative PSA levels >1.0ng/ml on two subsequent occasions, distant metastases or local recurrence (biopsy proven).
Of the 487 randomized patients, 21 were excluded because they were not eligible (cM1 disease in eight, cT1 in five, concurrent malignancy in two, a PSA of 105 at screening in one and postponed surgery because of concurrent disease in five). No data were available in 30 patients and 34 patients were lost to follow-up before surgery. Therefore, a total of 402 patients was used for evaluation: 192 in the NHT group, and 210 in the control group (direct radical prostatectomy). The distribution of patients according to stage and grade is presented in Table 45.1.
In the NHT group, mean prostate volume (measured with TRUS) decreased from 37.7 cm3 at baseline to 26.8 cm3 after 3 months of NHT. Mean PSA level likewise decreased from 20.5 ng/ml to 0.8 ng/ml after neoadjuvant treatment. In 33% of patients PSA became undetectable. No statistical significant differences could be found between the NHT group and the control group with regard to mean duration of surgery (163 and 159 minutes, P = 0.25), mean blood loss (1082 and 1150 ml,
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