Effects of a high dose, aglycone-rich soy extract on prostate-specific antigen and serum isoflavone concentrations in men with localized prostate cancer.

The efficacy and safety of consuming high-dose isoflavone supplements for prostate cancer is not clear. A double-blind, placebo controlled, randomized trial was conducted in 53 men with prostate cancer enrolled in an active surveillance program. The treatment group consumed a supplement containing 450 mg genistein, 300 mg daidzein, and other isoflavones daily for 6 mo. Prostate-specific antigen (PSA) was measured in both groups at baseline, 3 mo, and 6 mo, and serum concentrations of genistein, daidzein, and equol were assessed at baseline and 6 mo in the treatment group. Following the completion of the 6-mo double-blind study, men were enrolled in a 6-mo open label trial with the same isoflavone-rich supplement, and PSA was measured at 3 and 6 mo. PSA concentrations did not change in either group after 6 mo or after 12 mo when the open-label study was included. The 6 mo serum concentrations of genistein and daidzein (39.85 and 45.59 µmol/l, respectively) were significantly greater than baseline values and substantially higher than levels previously reported in other studies. Equol levels did not change. Although high amounts of aglycone isoflavones may result in significantly elevated serum concentrations of genistein and daidzein, these dietary supplements alone did not lower PSA levels in men with low-volume prostate cancer.

Modeling Clinical Processes to Consent Research Donors of Remnant Biospecimens in an Outpatient Cardiology Clinic.

Introduction: Informed consent for research biospecimen donations is traditionally obtained through a face-to-face interaction with research staff and by signing an Institutional Review Board (IRB)-approved printed form. Electronic signatures (eSign) are routinely used in the electronic medical record (EMR) for the consenting of clinical services after patients review printed documentation. Our goal was to develop an electronic self-consenting workflow that mimicked clinical services. Specifically, we tested a research consent process for the biobanking of remnant clinical samples that relies solely on clinical resources in a busy outpatient practice. Materials and Methods: The Biorepositories Core Resource (BCR) unit initiated a new enterprise-wide biobanking infrastructure for consenting patients, termed Biospecimen Use for Research-Related Investigations and Translational Objectives (BURRITO). BURRITO is modeled after an established clinical process called Terms and Conditions of Service (TACOS). The TACOS requires patients to annually review printed documentation and self-consent electronically for clinical services. BURRITO also requires patients to review printed documentation and self-consent with eSign to opt-in for remnant biospecimen banking, but patients must complete this process only once. We captured eSign for consents directly into the EMR without research staff. Results: Patients reviewed the IRB-approved documents and self-consented during their cardiology clinic visit. At checkout, their participation preferences were electronically documented by clinic staff. During a 6-month period, 123 patients agreed to donate. After a review of process, a second 3-month period identified 202 patients agreeing to donate. BURRITO did not require face-to-face interactions with research staff, used a "no-paper" eSign for consent, and created discrete fields in the clinical EMR of the patient's preference. Conclusions: BURRITO electronically documents informed consent using an EMR functionality and the least amount of clinical and research resources. Our results show promise for developing institutionally adopted processes, which could leverage existing clinical workflows for universal research consenting and scalability.

Effects of a genistein-rich extract on PSA levels in men with a history of prostate cancer.

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.

Effects of a mushroom mycelium extract on the treatment of prostate cancer.

OBJECTIVES: To determine whether supplemental amounts of a polysaccharide/oligosaccharide complex obtained from a shiitake mushroom extract (SME) would lower the prostate-specific antigen (PSA) level in patients with prostate cancer. METHODS: A total of 62 men (mean age 73.2 years, range 53.6 to 85.5) with histologically proven prostate cancer who had two consecutive elevated PSA readings were accrued to the study during a 3-month period. This was an open-label study in which the patients received oral administration of capsules containing SME given three times daily for 6 months. The endpoint for the trial was the lowering of the PSA levels. RESULTS: Of the 62 men enrolled in the study, 61 were assessable. At 4 months, 1 patient withdrew because of unrelated surgery and 7 withdrew because of disease progression; none had responded with a decrease of greater than 50% in the PSA level. By 6 months, a total of 23 patients had progression and none had responded. Thirty-eight patients had stable PSA levels after 6 months. Although not the primary endpoint of the study, in other studies these patients could have been included as responders. When the patients' rates of PSA rise before study entry were analyzed, 4 (7%) had stabilized disease while taking SME. Thus, the final results for our study patients were 0 with a complete response, 0 with a partial response, 4 (7%) with stable disease, and 23 of 61 with progression while taking SME. CONCLUSIONS: SME alone is ineffective in the treatment of clinical prostate cancer.