The impact of a Donor Human Milk Program on the provision of mothers' own milk at discharge in very low birth weight infants.

OBJECTIVE: Examine the effect of a donor human milk (DHM) program on mothers' own milk feedings at discharge for very low birth weight (VLBW) infants. STUDY DESIGN: A single center retrospective analysis of feeding outcomes in preterm infants. Data were assigned as: (1) pre DHM era (2) Bridge DHM era (3) Full DHM era. Each era was divided into infants <1500 g (n = 724) or ≥1500 g (n = 784). RESULTS: Both the percentage of mothers' own milk feeds and percent of infants exclusively receiving mothers' own milk at discharge were increased in the <1500 g (p = 0.003, p = 0.002) and the ≥1500 g group (p = 0.007, p = 0.004) respectively, following the introduction of DHM for VLBW infants. CONCLUSION: Practice changes that accompany a donor milk program likely play a prominent role in the provision of mothers' own milk and exclusivity of breast milk feedings at discharge for very low birth weight infants.

Mothers' Decision Making Concerning Safe Sleep for Preterm Infants: What Are the Influencing Factors?

BACKGROUND: Parental decisions regarding infant sleep practices vary widely, resulting in a lack of adherence to the American Academy of Pediatrics safe sleep recommendations (SSR) and consequently an increased risk of sudden infant death syndrome (SIDS). Preterm infants are among those at a highest risk for SIDS, yet few studies focus on parental decision-making surrounding sleep practices for preterm infants. PURPOSE: The purpose of this study was to identify factors influencing decisions concerning infant sleep practices of mothers of preterm infants. METHODS: This study used a mixed-methods design. Recruitment was through social media messaging by 2 parent support organizations. An online survey was used to assess factors influencing mothers' decisions regarding sleep practices for preterm infants. FINDINGS/RESULTS: Survey participants (n = 98) were from across the United States. Mothers of preterm infants (mean gestational age at birth = 29.42 weeks) most often reported positioning infants on their back to sleep (92.3%) and a low (15.4%) use of a pacifier at sleep time. Three themes emerged for the decisions made: adherence to SSR; nonadherence to SSR; and infant-guided decisions. Regardless of the decision, mothers indicated that anxiety over the infant's well-being resulted in a need for sleep practices that facilitated close monitoring of the infant. IMPLICATIONS FOR PRACTICE AND RESEARCH: The findings of this study indicate the need for understanding the underlying anxiety preventing mothers from adhering to SSR despite knowing them, along with tailoring infant sleep messaging and education to improve safety of sleep practices for preterm infants. Research is needed to examine decision making in more diverse populations.

Nivolumab plus ipilimumab, with or without enzalutamide, in AR-V7-expressing metastatic castration-resistant prostate cancer: A phase-2 nonrandomized clinical trial.

BACKGROUND: AR-V7-positive metastatic prostate cancer is a lethal phenotype with few treatment options and poor survival. METHODS: The two-cohort nonrandomized Phase 2 study of combined immune checkpoint blockade for AR-V7-expressing metastatic castration-resistant prostate cancer (STARVE-PC) evaluated nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg), without (Cohort 1) or with (Cohort 2) the anti-androgen enzalutamide. Co-primary endpoints were safety and prostate-specific antigen (PSA) response rate. Secondary endpoints included time-to-PSA-progression-free survival (PSA-PFS), time-to-clinical/radiographic-PFS, objective response rate (ORR), PFS lasting greater than 24 weeks, and overall survival (OS). RESULTS: Thirty patients were treated with ipilimumab plus nivolumab (N = 15, Cohort 1, previously reported), or ipilimumab plus nivolumab and enzalutamide (N = 15, Cohort 2) in patients previously progressing on enzalutamide monotherapy. PSA response rate was 2/15 (13%) in cohort 1 and 0/15 in cohort 2, ORR was 2/8 (25%) in Cohort 1 and 0/9 in Cohort 2 in those with measureable disease, median PSA-PFS was 3.0 (95% confidence interval [CI]: 2.1-NR) in cohort 1 and 2.7 (95% CI: 2.1-5.9) months in cohort 2, and median PFS was 3.7 (95% CI: 2.8-7.5) in cohort 1 and 2.9 (95% CI: 1.3-5.8) months in cohort 2. Three of 15 patients in cohort 1 (20%, 95% CI: 7.1%-45.2%) and 4/15 patients (26.7%, 95% CI: 10.5%-52.4%) in cohort 2 achieved a durable PFS lasting greater than 24 weeks. Median OS was 8.2 (95% CI: 5.5-10.4) in cohort 1 and 14.2 (95% CI: 8.5-NA) months in cohort 2. Efficacy results were not statistically different between cohorts. Grade-3/4 adverse events occurred in 7/15 cohort 1 patients (46%) and 8/15 cohort 2 patients (53%). Combined cohort (N = 30) baseline alkaline phosphatase and cytokine analysis suggested improved OS for patients with lower alkaline phosphatase (hazards ratio [HR], 0.30; 95% CI: 0.11-0.82), lower circulating interleukin-7 (IL-7) (HR, 0.24; 95% Cl: 0.06-0.93) and IL-6 (HR, 0.13; 95% Cl: 0.03-0.52) levels, and higher circulating IL-17 (HR, 4.53; 95% CI: 1.47-13.93) levels. There was a trend towards improved outcomes in men with low sPD-L1 serum levels. CONCLUSION: Nivolumab plus ipilimumab demonstrated only modest activity in patients with AR-V7-expressing prostate cancer, and was not sufficient to justify further exploration in unselected patients. Stratification by baseline alkaline phosphatase and cytokines (IL-6, -7, and -17) may be prognostic for outcomes to immunotherapy.

Oral Sucrose Versus Breastfeeding in Managing Infants' Immunization-Related Pain: A Randomized Controlled Trial.

BACKGROUND: Treating pain during immunization should be a part of pediatric primary healthcare around the world, as untreated pain in children has short- and long-term consequences. Few studies of pharmacologic and nonpharmacologic methods of pain relief during immunization have been conducted in low- and middle-income countries. Finding pain-mitigating interventions that are low-cost, effective, and feasible across all settings, including with low-resourced settings could improve primary healthcare. PURPOSE: To evaluate the effectiveness of oral sucrose versus breastfeeding as methods of pain management during immunization of infants through 6 months of age. METHODS: A randomized controlled experimental design was used; 120 infants were randomly assigned to control, sucrose, or breastfeeding groups. Data were collected in an Egyptian primary health center. Outcome measures including pain (as per the FLACC pain scale), crying time, and heart rate were measured at three time points. RESULTS: There were significant differences in pain scores and crying duration during and after immunization (p < .001) for the breastfeeding group compared with the sucrose and control groups. IMPLICATIONS FOR PRACTICE: Health staff and parents need education and support in use of breastfeeding for pain management during immunization. More studies are needed to evaluate effectiveness of breastfeeding versus other pain management methods for managing infants' immunization-related pain.

Ipilimumab plus nivolumab and DNA-repair defects in AR-V7-expressing metastatic prostate cancer.

AR-V7-expressing metastatic prostate cancer is an aggressive phenotype with poor progression-free survival (PFS) and overall survival (OS). Preliminary evidence suggests that AR-V7-positive tumors may be enriched for DNA-repair defects, perhaps rendering them more sensitive to immune-checkpoint blockade. We enrolled 15 metastatic prostate cancer patients with AR-V7-expressing circulating tumor cells into a prospective phase-2 trial. Patients received nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses, then maintenance nivolumab 3 mg/kg every 2 weeks. Targeted next-generation sequencing was performed to determine DNA-repair deficiency (DRD) status. Outcomes included PSA response rates, objective response rates (ORR), PSA progression-free survival (PSA-PFS), clinical/radiographic PFS and OS. Median age of participants was 65, median PSA was 115 ng/mL, 67% had visceral metastases, and 60% had ≥4 prior systemic therapies. Six of 15 men (40%) had DRD mutations (three in BRCA2, two in ATM, one in ERCC4; none had microsatellite instability). Overall, the PSA response rate was 2/15 (13%), ORR was 2/8 (25%) in those with measurable disease, median PSA-PFS was 3.0 (95%CI 2.1-NR) months, PFS was 3.7 (95%CI 2.8-7.5) months, and OS was 8.2 (95%CI 5.5-10.4) months. Outcomes appeared generally better in DRD+ vs. DRD- tumors with respect to PSA responses (33% vs. 0%; P=0.14, nonsignificant), ORR (40% vs. 0%; P=0.46, nonsignificant), PSA-PFS (HR 0.19; P<0.01, significant), PFS (HR 0.31; P=0.01, significant), and OS (HR 0.41; P=0.11, nonsignificant). There were no new safety concerns. Ipilimumab plus nivolumab demonstrated encouraging efficacy in AR-V7-positive prostate cancers with DRD mutations, but not in the overall study population.

Caring about Preemies' Safe Sleep (CaPSS): An Educational Program to Improve Adherence to Safe Sleep Recommendations by Mothers of Preterm Infants.

Preterm infants born before 37 weeks' gestation die of sudden infant death syndrome (SIDS) at a rate more than double that of term infants. There is a need for SIDS prevention programs tailored to the specific needs of parents of high-risk infants. The purpose of this study was to pilot test an online educational module addressing SIDS risk-reduction recommendations (RRRs) for parents of preterm infants. This study was conducted in a 44-bed transitional care unit at a level IV NICU in the Midwest. A repeated-measures design was used. Two weeks before discharge, mothers completed a survey, addressing knowledge and plans for caring for their baby at home. Mothers then viewed the 5-section Caring about Preemies' Safe Sleep (CaPSS) education module and completed the postmodule evaluation. A discharge survey was completed 4 weeks postdischarge. Fifteen mothers, mean age 26.4 years, participated; 8 (53%) returned the postdischarge survey. Module evaluation rated clarity and completeness of information high. Mothers' ratings of SIDS knowledge were significantly higher after viewing the module (P = .000) and 4 weeks after discharge home (P = .012). Mothers found the use of a pacifier at sleep times to be new information and changed their plans for caring for their infant, with 28.6% of mothers always offering a pacifier before sleep after discharge compared with the 6.7% who had planned to do this before discharge. However, only 71% of infants slept in parents' room after discharge and only 41% were receiving at least some breast milk, which are not consistent with SIDS RRRs.

Clinical Outcomes in Preterm Infants Following Institution of a Delayed Umbilical Cord Clamping Practice Change.

BACKGROUND: Evidence supports a significant reduction in the incidence of intraventricular hemorrhage (IVH) in preterm infants receiving delayed umbilical cord clamping (DCC). PURPOSE: This study evaluated clinical feasibility, efficacy, and safety outcomes in preterm infants (<36 weeks' gestational age) who received DCC following a practice change implementation intended to reduce the incidence of IVH. METHODS: Infants receiving DCC (45-60 seconds) were compared with a sample of infants receiving immediate umbilical cord clamping (<15 seconds) in a retrospective chart review (N = 354). The primary outcome measure was the prevalence of IVH. Secondary safety outcome measures of 1- and 5-minute Apgar scores, axillary temperature on neonatal intensive care unit admission, and initial 24-hour bilirubin level were also evaluated. Gestational age was examined for its effect on outcomes. RESULTS: Although the small number of infants with IVH precluded the ability to detect statistical significance, our raw data suggest DCC is efficacious in reducing the risk for IVH. For infants 29 or less weeks' gestational age, admission axillary temperature was significantly higher in those who received DCC. No differences were found in 1- and 5-minute Apgar scores, 24-hour bilirubin level, or hematocrit level between the two groups. Infants more than 29 weeks' gestational age who received DCC had significantly higher 1-minute Apgar scores, temperature, and 24-hour bilirubin level. IMPLICATIONS FOR PRACTICE: Clinicians should advocate for the implementation of DCC as part of the resuscitative process for preterm neonates. IMPLICATIONS FOR RESEARCH: Future studies are needed to evaluate the effect of DCC on other clinical outcomes and to investigate umbilical cord milking as an alternative approach to DCC.

The History and State of Neonatal Nursing Quality Improvement Practice and Education.

Quality improvement has evolved rapidly in neonatal nursing. This review outlines the history and current state of quality improvement practice and education in neonatal nursing. The future of neonatal nursing includes a stronger emphasis on quality improvement in advanced practice education that promotes doctoral projects that result in clinical improvements. A collective focus will ensure that neonatal nurses not only deliver evidence-based care, but also continually improve the care they deliver.

Implementing a Systematic Process for Consistent Nursing Care in a NICU: A Quality Improvement Project.

AIM: The global aim of this quality improvement project was to develop and implement a systematic process to assign and maintain consistent bedside nurses for infants and families. METHODS: A systematic process based on a primary care nursing model was implemented to assign consistent care for a 48-bed, single-family room NICU. RESULTS: Four PDSA cycles were necessary to obtain agreement from the nursing staff as to the best process for assigning primary nurses. Post-intervention data revealed a 9.5 percent decrease of consistent caregivers for infants in the NICU ≤ 28 days and a 2.3 percent increase of consistent caregivers for infants in the NICU ≥ 29 days. CONCLUSION: Although these findings did not meet the goal of the specific aim, a systematic process was created to assign bedside nurses to infants. Further PDSAs will be needed to refine the process to reach the aim.

Teaching Guatemalan traditional birth attendants about obstetrical emergencies.

INTRODUCTION: Guatemala's Maternal Mortality Rate is 65th highest in the world at 120 deaths per 100,000 births. Contributing to the problem is traditional birth attendants (TBAs) attend most births yet lack knowledge about obstetrical emergencies. Government trainings in existence since 1955 have not changed TBA knowledge. Government trainings are culturally insensitive because they are taught in Spanish with written material, even though most TBAs are illiterate and speak Mayan dialects. The purpose of the observational study was to evaluate the effect of an oral training, that was designed to be culturally sensitive in TBAs' native language, on TBAs' knowledge of obstetrical emergencies. METHODS: one hundred ninety-one TBAs participated. The study employed a pretest-posttest design. A checklist was used to compare TBAs' knowledge of obstetrical emergencies before and after the training. FINDINGS: the mean pretest score was 5.006±SD 0.291 compared to the mean posttest score of 8.549±SD 0.201. Change in knowledge was a P value of 0.00. DISCUSSION: results suggest an oral training that was designed to be culturally sensitive in the native language improved TBAs' knowledge of obstetrical emergencies. Future trainings should follow a similar format to meet the needs of illiterate audiences in remote settings.

Muscadine Grape Skin Extract (MPX) in Men with Biochemically Recurrent Prostate Cancer: A Randomized, Multicenter, Placebo-Controlled Clinical Trial.

Purpose: MuscadinePlus (MPX), a commercial preparation of pulverized muscadine grape skin, was evaluated as a therapeutic option for men with biochemically recurrent (BCR) prostate cancer wishing to defer androgen deprivation therapy.Experimental Design: This was a 12-month, multicenter, placebo-controlled, two-dose, double-blinded trial of MPX in 125 men with BCR prostate cancer, powered to detect a PSA doubling time (PSADT) difference of 6 months (low dose) and 12 months (high dose) relative to placebo. Participants were stratified (baseline PSADT, Gleason score) and randomly assigned 1:2:2 to receive placebo, 500 mg MPX (low), or 4,000 mg MPX (high) daily. Correlates included superoxide dismutase-2 (SOD2) genotype, lipid peroxidation, and polyphenol pharmacokinetics.Results: The evaluable population included 112 patients, all treated for at least 6 months and 62% treated for 12 months. No significant difference was found in PSADT change between control and treatment arms (P = 0.81): control 0.9 months (n = 20; range, 6.7-83.1), low dose 1.5 months (n = 52; range, 10.3-87.2), high dose 0.9 months (n = 40; range, 27.3-88.1). One high-dose patient experienced objective response. No drug-related CTCAE grade 3-4 adverse events were seen. In a preplanned exploratory analysis, PSADT pre-to-post increase was significant in the 27 (26%) genotyped patients with SOD2 Alanine/Alanine genotype (rs4880 T>C polymorphism) on MPX (pooled treatment arms; 6.4 months, P = 0.02), but not in control (1.8 months, P = 0.25).Conclusions: Compared with placebo, MPX did not significantly prolong PSADT in BCR patients over two different doses. Exploratory analysis revealed a patient population with potential benefit that would require further study. Clin Cancer Res; 24(2); 306-15. ©2017 AACR.

Adherence to Safe Sleep Recommendations by Families With Higher-order Multiples.

BACKGROUND: More than 95% of higher-order multiples are born preterm and more than 90% are low birth weight, making this group of infants especially vulnerable to sudden infant death syndrome (SIDS). Emerging evidence suggests that families with twins face challenges adhering to the American Academy of Pediatrics (AAP) recommendations to reduce SIDS risks. Adherence to the AAP recommendations in families with higher-order multiples has not been described. PURPOSE: This study describes SIDS risk reduction infant care practices for higher-order multiples during the first year of life. METHODS: Mothers caring for higher-order multiple-birth infants were recruited from an online support group. An online survey was used to assess infant care practices when the infants were first brought home from the hospital as well as at the time of the survey. RESULTS: Ten mothers of triplets and 4 mothers of quadruplets responded. Less than 80% of the mothers practiced "back to sleep" immediately postdischarge. Supine sleep positioning decreased over time, particularly during daytime naps. Only 50% of the infants shared the parents' bedroom and approximately 30% bed-shared with their siblings. Sleep-time pacifier use was low. IMPLICATIONS FOR PRACTICE: Safe sleep education must include specific questions regarding home sleeping arrangements, encouragement of breast milk feedings, supine positioning, and pacifier use at every sleep for higher-order multiple infants well before discharge in order for parents to plan a safe sleep environment at home. IMPLICATIONS FOR RESEARCH: Prospective studies to identify barriers and facilitators can inform future strategies supporting adherence to safe sleep practices for higher-order multiple infants.

Role of Baby-Friendly Hospital Care in Maternal Role Competence.

The objective of this pilot study was to determine women's perceptions of their levels of maternal role competence at discharge from a Baby-Friendly hospital. A convenience sample of 30 women completed two self-report questionnaires: a demographic questionnaire and the Perceived Maternal Parenting Self-Efficacy scale. Women report that they perceived high levels of maternal role competence with a mean total score of 69.80 (standard deviation = 6.86) out of 80. As women experience breastfeeding in Baby-Friendly hospitals, maternal role competence may develop with appropriate support.

A Password-Protected Web Site for Mothers Expressing Milk for Their Preterm Infants.

BACKGROUND: Research has demonstrated that breast milk significantly decreases morbidities that impact length of stay for preterm infants, but there is a need to test interventions to improve breastfeeding outcomes. Since many Americans are using technologies such as the Intranet and smartphones to find health information and manage health, a Web site was developed for mothers who provide breast milk for their preterm hospitalized infants. PURPOSE: This study examined the efficacy of a Web site for mothers to educate them about breast milk expression and assist them in monitoring their breast milk supply. METHODS: Quantitative and qualitative data were collected from mothers whose preterm infants were hospitalized in a level IV neonatal intensive care unit (NICU) or transitional care unit (TCU) in an urban academic medical center in the Midwest. RESULTS: Eighteen mothers participated in evaluation of the Web site. Thirteen mothers consistently logged on to the password-protected Web site (mean [standard deviation] = 13.3 [11.7]) times. Most participants, (69.2%), reported they used the breast milk educational information. Most mothers indicated that using the Web site log helped in tracking their pumping. These findings can be used to direct the design and development of web-based resources for mothers of preterm infants IMPLICATIONS FOR PRACTICE:: NICU and TCU staffs need to examine and establish approaches to actively involve mothers in monitoring the establishment and maintenance of an adequate supply of breast milk to improve neonatal health outcomes. IMPLICATIONS FOR RESEARCH: An electronic health application that incorporates the features identified in this study should be developed and tested.

Safe Sleep Infant Care Practices Reported by Mothers of Twins.

BACKGROUND: The high prevalence of prematurity and low birth-weight places twin infants at increased risk for sudden unexpected infant death (SUID) and/or sudden infant death syndrome (SIDS). Risk for these SUID and SIDS is affected by a combination of nonmodifiable intrinsic risk factors and modifiable extrinsic stressors including infant care practices related to sleep. Although adherence to the full scope of American Academy of Pediatrics (AAP) 2011 recommendations is intended to decrease risk, these recommendations are aimed at singleton infants and may require tailoring for families with multiple infants. PURPOSE: The study describes infant care practices reported by mothers of twins in the first 6 months postpartum. METHODS: Mothers caring for twin infants (N = 35) were surveyed online both longitudinally (at 2, 8, 16, and 24 weeks after infant hospital discharge) and cross-sectionally. AAP recommendations (2011) guided survey content. RESULTS: The degree of adherence to AAP recommendations varied over time. For example, mothers of twins reported 100% adherence to placing twins supine for sleep initially, but many reported putting babies on their stomachs for naps as twins became older. Sharing a parent's bedroom decreased over time as did frequency of crib sharing. Fewer than half of mothers offered a pacifier most or all of the time for sleep. IMPLICATIONS FOR PRACTICE: Opportunities exist for development of an educational program geared specifically for postpartum parents of twins. IMPLICATIONS FOR RESEARCH: Barriers affecting adherence to AAP recommendations and effectiveness of educational programs addressing needs of this unique population need further exploration.

Neonates and Infants Discharged Home Dependent on Medical Technology: Characteristics and Outcomes.

BACKGROUND: Preterm neonates and neonates with complex conditions admitted to a neonatal intensive care unit (NICU) may require medical technology (eg, supplemental oxygen, feeding tubes) for their continued survival at hospital discharge. Medical technology introduces another layer of complexity for parents, including specialized education about neonatal assessment and operation of technology. The transition home presents a challenge for parents and has been linked with greater healthcare utilization. PURPOSE: To determine incidence, characteristics, and healthcare utilization outcomes (emergency room visits, rehospitalizations) of technology-dependent neonates and infants following initial discharge from the hospital. METHODS: This descriptive, correlational study used retrospective medical record review to examine technology-dependent neonates (N = 71) upon discharge home. Study variables included demographic characteristics, hospital length of stay, and type of medical technology used. Analysis of neonates (n = 22) with 1-year postdischarge data was conducted to identify relationships with healthcare utilization. Descriptive and regression analyses were performed. FINDINGS: Approximately 40% of the technology-dependent neonates were between 23 and 26 weeks' gestation, with birth weight of less than 1000 g. Technologies used most frequently were supplemental oxygen (66%) and feeding tubes (46.5%). The mean total hospital length of stay for technology-dependent versus nontechnology-dependent neonates was 108.6 and 25.7 days, respectively. Technology-dependent neonates who were female, with a gastrostomy tube, or with longer initial hospital length of stay were at greater risk for rehospitalization. IMPLICATIONS FOR PRACTICE: Assessment and support of families, particularly mothers of technology-dependent neonates following initial hospital discharge, are vital. IMPLICATIONS FOR RESEARCH: Longitudinal studies to determine factors affecting long-term outcomes of technology-dependent infants are needed.

Supports and Barriers to Successful Progression in a DNP Program: Students' and Graduates' Perspectives.

This study examined the supports, barriers, and strategies to successful progression in a DNP program using a nationwide online survey of DNP students and graduates. Subjects (n = 172) had a mean age of 46.2 years; 83% worked full time. Major barriers were competing demands of work, family, and school. Perseverance was a key element in overcoming barriers; most students reported being overwhelmed, and 37% considered quitting. Mechanisms for programs to consider in addressing this stress are discussed.

A phase I study of muscadine grape skin extract in men with biochemically recurrent prostate cancer: Safety, tolerability, and dose determination.

BACKGROUND: New therapies are being explored as therapeutic options for men with biochemically recurrent prostate cancer (BRPC) who wish to defer androgen deprivation therapy. MPX is pulverized muscadine grape (Vitis rotundifolia) skin that contains ellagic acid, quercetin, and resveratrol and demonstrates preclinical activity against prostate cancer cells in vitro. METHODS: In the phase I portion of this phase I/II study, non-metastatic BRPC patients were assigned to increasing doses of MPX (Muscadine Naturals. Inc., Clemmons, NC) in cohorts of two patients, with six patients at the highest dose, using a modified continual reassessment method. Initial dose selection was based on preclinical data showing the equivalent of 500 to 4,000 mg of MPX to be safe in mouse models. The primary endpoint was the recommended phase II dosing regimen. RESULTS: The cohort (n = 14, 71% Caucasian, 29% black) had a median follow-up of 19.2 (6.2-29.7) months, median age of 61 years, and median Gleason score of 7. Four patients had possibly related gastrointestinal symptoms, including grade 1 flatulence, grade 1 soft stools, and grade 1 eructation. No other related adverse events were reported and one patient reported improvement of chronic constipation. Six of 14 patients came off study for disease progression (five metastatic, one rising PSA) after exposure for a median of 15 months. One patient came off for myasthenia gravis that was unrelated to treatment. Seven patients remain on study. The lack of dose-limiting toxicities led to the selection of 4,000 mg/d as the highest dose for further study. Median within-patient PSADT increased by 5.3 months (non-significant, P = 0.17). No patients experienced a maintained decline in serum PSA from baseline. CONCLUSION: These data suggest that 4,000 mg of MPX is safe, and exploratory review of a lengthening in PSADT of a median of 5.3 months supports further exploration of MPX. Both low-dose (500 mg) and high-dose (4,000 mg) MPX are being further investigated in a randomized, multicenter, placebo-controlled, dose-evaluating phase II trial.