PC-SPES: herbal formulation for prostate cancer - 31/08/11

Doi : 10.1016/S0090-4295(02)01913-1

Leonard S Marks ⁎, ^a,^b, Robert S DiPaola ^c, Peter Nelson ^d, Sophie Chen ^e,^{^{1
Dr. Chen was an initial co-holder of the U.S. patent for PC-SPES (U.S. patent 5,665,393 issued September 9, 1997); royalty fees were paid to her laboratory (NovaSpes Research Lab) by the manufacturer (BotanicLab, Brea, California) until December 31, 2001, when ownership of the patent was transferred to a charitable trust. She remains a stockholder in the company. Dr. Leaders has formerly been a paid consultant for BotanicLab. None of the other authors has any financial involvement with the manufacturer or the product.}}, David Heber ^b, Arie S Belldegrun ^b, Franklin C Lowe ^f, John Fan ^a, Floyd E Leaders ^g, Allan J Pantuck ^b, Varro E Tyler ^h,^{†
Deceased.}
^a Urological Sciences Research Foundation, Culver City, California, USA
^b Departments of Urology and Medicine, University of California, Los Angeles, School of Medicine, Los Angeles, California, USA
^c Cancer Institute of New Jersey and Department of Medicine, New Jersey School of Medicine and Dentistry-Robert Wood Johnson School of Medicine, New Brunswick, New Jersey, USA
^d Fred Hutchinson Cancer Center and Department of Medicine, University of Washington School of Medicine, Seattle, Washington, USA
^e Department of Medicine, New York Medical College, Valhalla, New York, USA
^f Department of Urology, Columbia University School of Medicine, New York, New York, USA
^g Botanical Enterprises, Inc., BEI-Botanicals, Rockville, Maryland, USA
^h Purdue University School of Pharmacy and Pharmacal Sciences, West Lafayette, Indiana, USA

^*Reprint requests: Leonard S. Marks, M.D., Urological Sciences Research Foundation, Culver Medical Plaza, 3831 Hughes Avenue, Suite 700, Culver City, CA 90232, USA

Abstract

PC-SPES is a potent eight-herb formulation sold directly to consumers; it has promising efficacy in the treatment of prostate cancer (CaP). The product induces a castrate status in most, if not all, men, resulting in a 50% or greater prostate-specific antigen reduction in the great majority of men with androgen-dependent CaP and in more than one half of the men with androgen-independent CaP. The duration of response is not yet clear. The efficacy of PC-SPES appears to exceed that of androgen ablation alone, but is not necessarily separate from an estrogenic effect. Common side effects include gynecomastia, nipple tenderness, loss of libido, and impotency; uncommon side effects include a 4% incidence of thromboembolic phenomena, but also two reports of bleeding diatheses. The mechanisms of action may involve downregulation of the androgen receptor, induction of apoptosis by way of inhibition of the bcl-2 gene, and increased expression of p53. Two marker compounds in PC-SPES are baicalin and oridonin, both of which exhibit antiproliferative effects in CaP cell lines. Thousands of men are currently obtaining this nonprescription medicine, and physicians should ask patients specifically about its use. PC-SPES is of great interest in men with androgen-independent CaP, an area in which future research should be primarily directed.

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