{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T10:01:55Z","timestamp":1785578515548,"version":"3.56.0"},"reference-count":20,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"18","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2004,9,15]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> To evaluate the herbal combination, PC-SPES, and diethylstilbestrol (DES) in patients with androgen independent prostate cancer (AIPC). <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> A randomized phase II study was conducted with cross-over design. Patients were randomly assigned to receive either three PC-SPES capsules orally three times a day or DES 3 mg orally once a day. Prophylactic warfarin was administered. At clinical or prostate-specific antigen progression, patients received the other therapy. The study closed prematurely after PC-SPES was withdrawn from the market. Chemical analyses were performed on multiple lots of PC-SPES. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Ninety patients were enrolled, of whom 85 were assessable for response. Prostate-specific antigen declines \u2265 50% were noted in 40% (95% CI, 25% to 56%) with PC-SPES, and 24% (95% CI, 12% to 39%) with DES. Median response duration was not reached with PC-SPES, and was 3.8 months with DES. Median time to progression for randomly assigned patients was 5.5 months for PC-SPES and 2.9 months for DES. Common toxicities included mild fatigue, gynecomastia, and mastodynia. Five thromboembolic events occurred (one PC-SPES, four DES). Responses in the cross-over phase were inconclusive. Four lots of PC-SPES had measurable quantities of DES, ranging from 0.01% to 3.1% of the dose used in the DES arm. Ethinyl estradiol was also detected in PC-SPES lots. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> PC-SPES and DES demonstrate activity in AIPC and are well tolerated. However, the synthetic estrogens, DES and ethinyl estradiol, were detected in various lots of PC-SPES, including those used in this trial. Clinical trials that utilize herbal therapies must account for issues of purity and consistency. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2004.10.195","type":"journal-article","created":{"date-parts":[[2004,8,3]],"date-time":"2004-08-03T00:24:34Z","timestamp":1091492674000},"page":"3705-3712","source":"Crossref","is-referenced-by-count":92,"title":["Prospective, Multicenter, Randomized Phase II Trial of the Herbal Supplement, PC-SPES, and Diethylstilbestrol in Patients With Androgen-Independent Prostate Cancer"],"prefix":"10.1200","volume":"22","author":[{"given":"William K.","family":"Oh","sequence":"first","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip W.","family":"Kantoff","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivian","family":"Weinberg","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graham","family":"Jones","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian I.","family":"Rini","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mika K.","family":"Derynck","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Bok","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew R.","family":"Smith","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn J.","family":"Bubley","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert T.","family":"Rosen","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; Department of Chemistry, Northeastern University; Massachusetts General Hospital Cancer Center; Beth Israel Deaconess Medical Center, Boston, MA; Department of Food Science and Center for Advanced Food Technology, Rutgers University; University of Medicine and Dentistry of New Jersey, Piscataway, NJ; and University of California, San Francisco Comprehensive Cancer Center, San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S.","family":"DiPaola","sequence":"additional","affiliation":[{"name":"From the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute; 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