title: A Phase II trial of a combination herbal supplement for men with biochemically recurrent prostate cancer.
abstract: BACKGROUND
  Men with biochemical recurrence (BCR) of prostate cancer are typically observed or treated with androgen-deprivation therapy. Non-hormonal, non-toxic treatments to slow the rise of PSA are desirable. We studied a combination herbal supplement, Prostate Health Cocktail (PHC), in prostate cancer cell lines and in a population of men with BCR.
  
  
  METHODS
  PC3, LAPC3 and LNCaP cells were incubated with increasing concentrations of PHC suspension. Men previously treated for prostate cancer with surgery, radiation or both with rising PSA but no radiographic metastases were treated with three capsules of PHC daily; the primary end point was 50% PSA decline. Circulating tumor cells (CTCs) were identified using parylene membrane filters.
  
  
  RESULTS
  PHC showed a strong dose-dependent anti-proliferative effect in androgen-sensitive and independent cell lines in vitro and suppression of androgen receptor expression. Forty eligible patients were enrolled in the clinical trial. Median baseline PSA was 2.8 ng ml(-1) (1.1-84.1) and 15 men (38%) had a PSA decline on study (1-55% reduction); 25 (62%) had rising PSA on study. The median duration of PSA stability was 6.4 months. Two patients had grade 2/3 transaminitis; the only other grade 2 toxicities were hyperglycemia, hypercalcemia and flatulence. There were no significant changes in testosterone or dihydrotestosterone. CTCs were identified in 19 men (47%).
  
  
  CONCLUSIONS
  Although the primary end point was not met, PHC was well tolerated and was associated with PSA declines and stabilization in a significant number of patients. We believe this is the first report of detecting CTCs in men with BCR prostate cancer. Randomized studies are needed to better define the effect of PHC in men with BCR.
authors.affiliation: Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
authors.forename: T B
authors.initials: TB
authors.lastname: Dorff
authors.affiliation: Division of Biostatistics, Department of Preventive Medicine, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Groshen
authors.affiliation: Division of Biostatistics, Department of Preventive Medicine, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
authors.forename: D D
authors.initials: DD
authors.lastname: Tsao-Wei
authors.affiliation: Division of Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Xiong
authors.affiliation: Keck School of Medicine, Westside Prostate Cancer Center, Center for Applied Molecular Medicine, University of Southern California, Los Angeles, CA, USA.
authors.forename: M E
authors.initials: ME
authors.lastname: Gross
authors.affiliation: Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.
authors.forename: N
authors.initials: N
authors.lastname: Vogelzang
authors.affiliation: Division of Medical Oncology, Department of Medicine, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
authors.forename: D I
authors.initials: DI
authors.lastname: Quinn
authors.affiliation: Division of Medical Oncology, Department of Medicine, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
authors.forename: J K
authors.initials: JK
authors.lastname: Pinski
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001669:Biochemical Phenomena; D015153:Blotting, Western; D045744:Cell Line, Tumor; D049109:Cell Proliferation / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D008517:Phytotherapy / Q000009:adverse effects / Q000379:methods*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy*
chemical_list: D017430:Prostate-Specific Antigen