Originally published as JCO Early Release 10.1200/JCO.2004.10.195 on August 2 2004

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Prospective, Multicenter, Randomized Phase II Trial of the Herbal Supplement, PC-SPES, and Diethylstilbestrol in Patients With Androgen-Independent Prostate Cancer

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

Address reprint requests to Eric J. Small, MD, UCSF Comprehensive Cancer Center, 1600 Divisadero St, A718, San Francisco, CA 94115; e-mail: smalle{at}medicine.ucsf.edu

PURPOSE: To evaluate the herbal combination, PC-SPES, and diethylstilbestrol (DES) in patients with androgen independent prostate cancer (AIPC).

PATIENTS AND METHODS: 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 The study closed prematurely after PC-SPES was withdrawn from the market.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.

RESULTS: Ninety patients were enrolled, of whom 85 were assessable for response. Prostate-specific antigen declines 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.

CONCLUSION: 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.

Supported by a grant from the C. Brendan Noonan Jr. Charitable Foundation (to W.K.O.) and CaPCURE (to E.J.S.).

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18–21, 2002.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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