Modified Citrus Pectin Treatment in Non-Metastatic Biochemically Relapsed Prostate Cancer: Long-Term Results of a Prospective Phase II Study.

The optimal therapy for patients with non-metastatic biochemically relapsed prostate cancer (BRPC-M0) after local therapy is elusive. Thus, the evaluation of new non-toxic compounds in BRPC-M0 patients is warranted. PectaSol®-Modified citrus pectin (P-MCP) is a food supplement categorized as GRAS (Generally Recognized As Safe) by the FDA. It is a competitive inhibitor of the galectin-3 protein, which is involved in cancer pathogenesis. In an early report of the present phase 2 study, P-MCP treatment for 6 months led to prostate-specific antigen doubling time (PSADT) improvement in 75% of patients with BRPC-M0. Herein, we report the second long-term treatment phase of an additional 12 months of P-MCP therapy (4.8 g × 3/day orally) in patients without disease progression after the initial 6 months of therapy. Of the 46 patients that entered the second treatment phase, 7 patients withdrew consent and decided to continue therapy out of pocket, and 39 initiated the second treatment phase. After a total of 18 months of P-MCP treatment, 85% (n = 33) had a durable long-term response, with 62% (n = 24) showing decreased/stable PSA, 90% (n = 35) PSADT improvement, and all with negative scans. No patient had grade 3/4 toxicity. In conclusion, P-MCP may have long-term durable efficacy and is safe in BRPC-M0.

Modified Citrus Pectin Treatment in Non-Metastatic Biochemically Relapsed Prostate Cancer: Results of a Prospective Phase II Study.

Optimal therapy of biochemically relapsed prostate cancer (BRPC) after local treatment is elusive. An established modified citrus pectin (PectaSol®, P-MCP), a dietary polysaccharide, is an established antagonist of galectin-3, a carbohydrate-binding protein involved in cancer pathogenesis. Based on PSA dynamics, we report on the safety and the primary outcome analysis of a prospective phase II study of P-MCP in non-metastatic BRPC based. Sixty patients were enrolled, and one patient withdrew after a month. Patients (n = 59) were given P-MCP, 4.8 grams X 3/day, for six months. The primary endpoint was the rate without PSA progression and improved PSA doubling time (PSADT). Secondary endpoints were the rate without radiologic progression and toxicity. Patients that did not progress by PSA and radiologically at six months continued for an additional twelve months. After six months, 78% (n = 46) responded to therapy, with a decreased/stable PSA in 58% (n = 34), or improvement of PSADT in 75% (n = 44), and with negative scans, and entered the second twelve months treatment phase. Median PSADT improved significantly (p = 0.003). Disease progression during the first 6 months was noted in only 22% (n = 13), with PSA progression in 17% (n = 10), and PSA and radiologic progression in 5% (n = 3). No patients developed grade 3 or 4 toxicity.

Prevalence and predictors of selenium and vitamin E supplementation in a urology population.

OBJECTIVES: Preclinical and epidemiological studies have suggested the use of supplements such as selenium and vitamin E for prostate cancer (PCa) prevention; however, clinical trials have not demonstrated clear benefit in patients. This study aims to investigate the current prevalence and predictors for use of these supplements in men in a urology population. DESIGN, SUBJECTS, AND OUTCOMES MEASURED: Three hundred and twelve (312) men visiting the Princess Margaret Hospital Ambulatory Urology Clinic were enrolled in this University Health Network Research Ethics Board-approved questionnaire-based study investigating supplement use, reasons for use and demographic characteristics. RESULTS: It was observed that 13.5% and 20.8% of the participants are currently using selenium and vitamin E, respectively, while 10.6% and 15.7% previously used selenium and vitamin E, respectively. Both education (percentage of users comparing less than college education versus college or above education: selenium: 14% versus 28%; p=0.008, vitamin E: 26% versus 41%; p=0.013) and health literacy (mean scores±standard error of the mean of users versus nonusers: selenium question 1: 1.4507±0.09576 versus 1.6083±0.07211; p=0.023, selenium question 2: 2.8750±0.04395 versus 2.7106±0.03774; p=0.000, selenium question 3: 1.4583±0.08377 versus 1.7064±0.06278; p=0.025, vitamin E question 1: 2.8036±0.04545 versus 2.7179±0.04097; p=0.010, vitamin E question 2: 1.5446±0.06698 versus 1.7077±0.07241; p=0.006) are predictors of selenium and vitamin E use on univariable analysis. On multivariable analysis education (selenium odds ratio=2.095, 95% confidence interval=1.019-4.305, p=0.044; vitamin E odds ratio=1.855, 95% confidence interval=1.015-3.338, p=0.045) remains a significant predictor of selenium and vitamin E use. Examining the data on use by education, it was found that more men with a higher education attributed their use of selenium to urologist advice (24%), and those with a lower education attributed their use of selenium to naturopath/homeopath advice (28%). CONCLUSIONS: Many men who visit urology clinics use selenium and vitamin E despite the lack of clinical support for chemoprevention. Education and health literacy are important variables in determining the use of these supplements in these men. This information may aid in addressing the needs of the diverse patient population using these supplements for the prevention of PCa.

Predictors of nocturia quality of life before and shortly after prostatectomy.

OBJECTIVES: To evaluate the predictors of nocturia-related quality of life and to assess the early effect of prostatectomy on these parameters in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. METHODS: The study group included 56 consecutive patients scheduled for prostatectomy to treat medical treatment-refractory lower urinary tract symptoms. Nocturia severity was assessed preoperatively and 2 to 3 months after prostatectomy by the number of nocturia events, time from falling sleep to first awakening to void (hours of undisturbed sleep [HUS]), longest sleep interval between voids, and score on the nocturia quality-of-life (N-QOL) questionnaire (range 0 to 48). RESULTS: The mean age of the study group was 69 +/- 9 years. The preoperative N-QOL score correlated strongly with the number of nocturia events, HUS, and longest sleep interval between voids (r = -0.69, r = 0.67, and r = 0.69, respectively, and P <0.001). Of the 56 patients, 36 (65%) underwent transurethral prostatectomy and 20 (35%) underwent open prostatectomy. Significant improvement (P <0.001) was noted in all factors after treatment. The number of nocturia events decreased from 3.4 +/- 1.2 to 2.6 +/- 0.99; the HUS increased from 1.83 +/- 0.55 to 2.74 +/- 0.64 hours; the longest sleep interval between voids increased from 2.36 +/- 0.64 to 2.91 +/- 0.6 hours; and the N-QOL score increased from 24.1 +/- 7 to 34.4 +/- 7.5. On multivariate stepwise regression analysis, the factors predicting for improvement in the N-QOL score after prostatectomy were the number of nocturia events and HUS. CONCLUSIONS: Prostatectomy is associated with an early postoperative improvement in nocturia indexes. The increases in the interval to first void and decrease in even less than one nocturia event were associated with significant improvement in nocturia quality of life.