PubMed1986
Phase III trials began since 1960 with the VACURG's studies and their results are sometimes difficult to interpret because of the variability of staging, classification, criteria of response, preliminary nature of some of them. Twenty three trials published between 1973 and 1984 are analyzed: 14 concerning advanced disease. 9 concerning loco-regional disease. For advanced disease, cyproterone acetate is not better than DES (3 mg), but a sufficient dose of Estracyt (10 mg/kg) seems to work better with less toxicity (Wisconsin trial). Among traditional hormonal manipulations, sub-capsular orchidectomy appeared to be better. The absence of results of ongoing trials with LHRH analogues, castration and anti-androgen combination do not allow an approach of their respective role. Chemotherapy has several efficacious compounds, CTM, 5FU, MTX, CDDP, ADM, which may be required after failure of hormonotherapy. Their association may take into account age and bone marrow reserves. For loco-regional disease NPCP protocols 900 and 1000 will focus indications of prostatectomy, cryosurgery, radiotherapy for stages B2, C, D1, as well as those of adjuvant treatment which will be probably modulated by prognostic factors such as stage, differentiation, lymph node status. For pelvic irradiation, the Standford trial make it easier to determine the target volume in correlation with lymph node status.