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Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer.
Urology 2004; 63(2):259-63U

Abstract

OBJECTIVES

To determine whether supplemental amounts of soy isoflavone (genistein-rich extract) would lower prostate-specific antigen (PSA) levels more than 50% in patients with prostate cancer (CaP).

METHODS

A total of 62 men (mean age 73.6 years, range 61.4 to 89.3) with histologically proven CaP who had two consecutive elevated PSA readings were accrued during a 13-month period. An open-label pilot study was conducted for 6 months in which the patients took capsules containing the genistein-rich extract three times daily by mouth. The subjects were in one of five groups: after radical retropubic prostatectomy (n = 9), after radiotherapy (n = 17), after both radical retropubic prostatectomy and radiotherapy (n = 6), off-cycle during hormonal therapy (intermittent hormones; n = 14), or active surveillance (n = 16). The primary endpoint for the trial was a 50% reduction in the PSA level at 6 months compared with before treatment.

RESULTS

Of the 62 men enrolled, 52 were available for evaluation at 6 months. Three patients discontinued because of adverse events (diarrhea) and seven because of personal choice. One of 52 patients had a more than 50% reduction in the PSA level (1.9% response, 95% confidence interval 0.1% to 10.3%). An additional 7 patients had PSA reductions that were less than 50%. All 8 patients with lower PSA levels at 6 months were in the active surveillance (watchful waiting) treatment subgroup. Repeated measure regression models allowing for correlation between initial levels and change also indicated a decline in PSA in this group compared with other groups: 0 of 52 had a complete response, 9 (17%) had a partial response, 8 (15%) had stable disease, and 35 (67%) had disease progression. In the 9 patients with a partial response, 6 had pathologic findings that were moderately differentiated, 2 had well-differentiated findings, and 1 had poorly differentiated findings. Therefore, the response in this group of patients did not appear to be driven by the Gleason score. The total testosterone level was lowered in one of the patients responding, but it was higher in five others.

CONCLUSIONS

A genistein-rich extract as the sole treatment for CaP did not reduce PSA levels by 50% or more in 51 of 52 subjects. Thus, it does not appear to be an effective treatment for CaP when given alone. However, 8 of 13 evaluated patients in the active surveillance group had either no rise or a decline in PSA levels of less than 50%. More study is warranted for those choosing active surveillance.

Authors+Show Affiliations

Department of Urology, University of California, Davis, School of Medicine, Sacramento, California 95817, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Controlled Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14972467

Citation

deVere White, Ralph W., et al. "Effects of a Genistein-rich Extract On PSA Levels in Men With a History of Prostate Cancer." Urology, vol. 63, no. 2, 2004, pp. 259-63.
deVere White RW, Hackman RM, Soares SE, et al. Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. Urology. 2004;63(2):259-63.
deVere White, R. W., Hackman, R. M., Soares, S. E., Beckett, L. A., Li, Y., & Sun, B. (2004). Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. Urology, 63(2), pp. 259-63.
deVere White RW, et al. Effects of a Genistein-rich Extract On PSA Levels in Men With a History of Prostate Cancer. Urology. 2004;63(2):259-63. PubMed PMID: 14972467.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer. AU - deVere White,Ralph W, AU - Hackman,Robert M, AU - Soares,Stephanie E, AU - Beckett,Laurel A, AU - Li,Yueju, AU - Sun,Buxiang, PY - 2003/05/14/received PY - 2003/09/25/accepted PY - 2004/2/20/pubmed PY - 2004/6/15/medline PY - 2004/2/20/entrez SP - 259 EP - 63 JF - Urology JO - Urology VL - 63 IS - 2 N2 - OBJECTIVES: To determine whether supplemental amounts of soy isoflavone (genistein-rich extract) would lower prostate-specific antigen (PSA) levels more than 50% in patients with prostate cancer (CaP). METHODS: A total of 62 men (mean age 73.6 years, range 61.4 to 89.3) with histologically proven CaP who had two consecutive elevated PSA readings were accrued during a 13-month period. An open-label pilot study was conducted for 6 months in which the patients took capsules containing the genistein-rich extract three times daily by mouth. The subjects were in one of five groups: after radical retropubic prostatectomy (n = 9), after radiotherapy (n = 17), after both radical retropubic prostatectomy and radiotherapy (n = 6), off-cycle during hormonal therapy (intermittent hormones; n = 14), or active surveillance (n = 16). The primary endpoint for the trial was a 50% reduction in the PSA level at 6 months compared with before treatment. RESULTS: Of the 62 men enrolled, 52 were available for evaluation at 6 months. Three patients discontinued because of adverse events (diarrhea) and seven because of personal choice. One of 52 patients had a more than 50% reduction in the PSA level (1.9% response, 95% confidence interval 0.1% to 10.3%). An additional 7 patients had PSA reductions that were less than 50%. All 8 patients with lower PSA levels at 6 months were in the active surveillance (watchful waiting) treatment subgroup. Repeated measure regression models allowing for correlation between initial levels and change also indicated a decline in PSA in this group compared with other groups: 0 of 52 had a complete response, 9 (17%) had a partial response, 8 (15%) had stable disease, and 35 (67%) had disease progression. In the 9 patients with a partial response, 6 had pathologic findings that were moderately differentiated, 2 had well-differentiated findings, and 1 had poorly differentiated findings. Therefore, the response in this group of patients did not appear to be driven by the Gleason score. The total testosterone level was lowered in one of the patients responding, but it was higher in five others. CONCLUSIONS: A genistein-rich extract as the sole treatment for CaP did not reduce PSA levels by 50% or more in 51 of 52 subjects. Thus, it does not appear to be an effective treatment for CaP when given alone. However, 8 of 13 evaluated patients in the active surveillance group had either no rise or a decline in PSA levels of less than 50%. More study is warranted for those choosing active surveillance. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/14972467/Effects_of_a_genistein_rich_extract_on_PSA_levels_in_men_with_a_history_of_prostate_cancer_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090429503010665 DB - PRIME DP - Unbound Medicine ER -