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OBJECTIVE This prospective and randomized clinical study was initiated to compare the efficacy and safety of combined androgen blockade with combination with UFT in patients with untreated prostate cancer. METHODS A total of 142 patients were entered in this study between April 1990 and December 1992. All patients received bilateral orchiectomy and 200 mg/day of diethylstilbestrol diphosphate. Of these patients, 70 patients were administered an additional 400 mg/day of UFT after randomization. Either treatment was continued for at least 1 year or until objective progression occurred if the initial response was equal to or better than no change. The endpoints of this study were progression-free survival, cancer-specific survival and change of QOL scores. RESULTS A total of 136 patients were evaluable and 131 patients (96.3%) could be followed up with a median follow-up period of 1469 days. Both groups showed similar initial treatment response at 12 weeks, adverse effect and change of quality of life score during the first year after initiation of the treatment. There was a significantly longer progression-free survival and better but not significant cancer-specific survival in the endocrine chemotherapy group. The patients with earlier stage and initial serum prostate-specific antigen values

Background: The ratio of free PSAin total PSA(fit) has been reported to improve the diagnostic accuracy of prostate cancer in the groupwith slightly elevated serum PSA values. In Japanese cases, the clinical significance of fit is still controversial. Methods: The diagnostic significance of fit in serum for prostate cancer was evaluated in a cooperative study. A total of 77 cases with prostate cancer and 224 with non-prostate cancer showing less than 20 ng/ml of total PSAwere evaluated. Results: Serum total and free PSA values were not affected by storage at 25°C for 2 days. The determination of fit was useful in the cases with a serum total PSA of 5.1-10 ng/ml; the specificity was 60% with a sensitivity of 90% at an fit of 0.148. The positive predictive value for diagnosis of prostate cancer also increased to 54%from 34% of that in total PSA alone. In the range of 4.1-10 ng/ml, the cut-off value of fit was 0.155 for obtaining relatively high specificity; sensitivity was 85% and specificity was 56.5%. Conclusions: Thus, thedetermination offit wasconsidered to beaneffective tool fordiscriminating the non-prostate cancer cases from those of prostate cancer.

Serum prostate-specific antigen and prostatic acid phosphatase were simultaneously evaluated in 22 healthy males, 29 patients with benign prostatic hypertrophy, and 192 patients with prostate cancers at various stages as well as in 30 patients with cancers other than prostate cancer. Both markers were quantitated by specific sandwich-type, enzyme-linked, immunosorbent assays with the use of specific antiserum reagents. Serum assays revealed a discordance between these two markers; thus expressions of these two biochemically and immunologically distinct prostate-specific proteins may reflect different aspects in the biology of prostate cancer. A combination test with the use of 7.5 ng of prostate antigen and 15.5 ng of prostatic acid phosphatase/ml of serum, respectively, as cutoff values resulted in a positive detection rate of 58% for prostate cancers of stages A (7/12) and B (21/36) each, 68% for prostate cancer of stage C (19/28), 92% for prostate cancer of stage D (106/116), and only 10% for benign prostatic hypertrophy (3/29). None of 52 other cancers or healthy controls was registered as positive. This study demonstrates that a multiple marker test of tissue-specific antigens can be of an additive value in the immunodiagnosis of cancer and may be a logical and effective approach at this time, in light of the unavailability of human tumor-specific markers.

Specificity of a previously reported prostate antigen (PA) was assessed by several immunologic procedures. This antigen, restricted in distribution to the prostate gland, was detected within ductal epithelial cells. Continuous established cell lines LNCaP and PC-3 of malignant prostate origin retained the expression of PA. Tumor cells released the antigen in vitro into the culture fluid and also in vivo into the circulation of nude mice preinoculated with LNCaP cells. Prostate cells in culture also specifically accreted immunoglobulin fragments of PA antiserum.