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Clinical Research

A Phase II trial of a combination herbal supplement for men with biochemically recurrent prostate cancer

Prostate Cancer and Prostatic Diseases volume 17, pages 359–365 (2014)Cite this article

Subjects

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.

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Acknowledgements

This study was supported by the Whittier Foundation, with additional support from the Cancer Center Core Grant Grant P30 CA014089.

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Authors and Affiliations

  1. Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA

    T B Dorff

  2. Division of Biostatistics, Department of Preventive Medicine, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA

    S Groshen & D D Tsao-Wei

  3. Division of Medical Oncology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

    S Xiong

  4. Keck School of Medicine, Westside Prostate Cancer Center, Center for Applied Molecular Medicine, University of Southern California, Los Angeles, CA, USA

    M E Gross

  5. Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA

    N Vogelzang

  6. Division of Medical Oncology, Department of Medicine, Keck School of Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA

    D I Quinn & J K Pinski

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Correspondence to T B Dorff.

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Competing interests

Dr Pinski holds the patent for Prostate Health Cocktail and has commercial interest in the company that distributes it, OncoNatural Solutions. The other authors declare no conflict of interest.

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Dorff, T., Groshen, S., Tsao-Wei, D. et al. A Phase II trial of a combination herbal supplement for men with biochemically recurrent prostate cancer. Prostate Cancer Prostatic Dis 17, 359–365 (2014). https://doi.org/10.1038/pcan.2014.37

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