{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T13:20:43Z","timestamp":1789737643653,"version":"4.0.1"},"reference-count":25,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"36","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2008,12,20]]},"abstract":"Purpose<\/jats:title> We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease. <\/jats:p><\/jats:sec>Patients and Methods<\/jats:title> Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy. <\/jats:p><\/jats:sec>Results<\/jats:title> Three hundred six patients were registered; 286 are reported. Median time to progression was 24 months (95% CI, 18 to 39 months) in the standard therapy arm, and 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). At median follow-up of 6.4 years, overall survival was 5.4 years (95% CI, 4.7 to 7.8 years) in the standard therapy arm versus 6.1 years (95% CI, 5.1 to 10.1 years; P = .41). Prostate-specific antigen kinetics at the time of androgen ablation and the nadir after hormone treatment were strongly correlated with survival. Chemotherapy significantly increased the burden of therapy, with 51% of patients experiencing an adverse event of grade 3 or worse, especially thromboembolic events. <\/jats:p><\/jats:sec>Conclusion<\/jats:title> There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2007.15.9830","type":"journal-article","created":{"date-parts":[[2008,11,25]],"date-time":"2008-11-25T02:26:12Z","timestamp":1227579972000},"page":"5936-5942","source":"Crossref","is-referenced-by-count":79,"title":["Phase III Trial of Androgen Ablation With or Without Three Cycles of Systemic Chemotherapy for Advanced Prostate Cancer"],"prefix":"10.1200","volume":"26","author":[{"given":"Randall E.","family":"Millikan","sequence":"first","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sijin","family":"Wen","sequence":"additional","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lance C.","family":"Pagliaro","sequence":"additional","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa A.","family":"Brown","sequence":"additional","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenda","family":"Moomey","sequence":"additional","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim-Anh","family":"Do","sequence":"additional","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J.","family":"Logothetis","sequence":"additional","affiliation":[{"name":"From the Departments of Genitourinary Medical Oncology and Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"R1","doi-asserted-by":"publisher","DOI":"10.3322\/canjclin.57.1.43"},{"key":"R2","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19930201)71:3+<1098::AID-CNCR2820711432>3.0.CO;2-G"},{"key":"R3","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0045(20001001)45:2<184::AID-PROS13>3.0.CO;2-K"},{"key":"R4","unstructured":"Ellerhorst JA, Tu SM, Amato RJ, et al: Phase II trial of alternating weekly chemohormonal therapy for patients with androgen-independent prostate cancer. 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