BACKGROUND: Patients with localized, unfavorable intermediate-risk and high-risk prostate cancer have an increased risk of relapse after radical prostatectomy (RP). The authors previously reported on part 1 of this phase 2 trial testing neoadjuvant apalutamide, abiraterone, prednisone, plus leuprolide (AAPL) or abiraterone, prednisone, and leuprolide (APL) for 6 months followed by RP. The results demonstrated favorable pathologic responses (tumor <5 mm) in 20.3% of patients (n = 24 of 118). Herein, the authors report the results of part 2.
METHODS: For part 2, patients were randomized 1:1 to receive either AAPL for 12 months (arm 2A) or observation (arm 2B), stratified by neoadjuvant therapy and pathologic tumor classification. The primary end point was 3-year biochemical progression-free survival. Secondary end points included safety and testosterone recovery (>200 ng/dL).
RESULTS: Overall, 82 of 118 patients (69%) enrolled in part 1 were randomized to part 2. A higher proportion of patients who were not randomized to adjuvant therapy had a favorable prostatectomy pathologic response (32.3% in nonrandomized patients compared with 17.1% in randomized patients). In the intent-to-treat analysis, the 3-year biochemical progression-free survival rate was 81% for arm 2A and 72% for arm 2B (hazard ratio, 0.81; 90% confidence interval, 0.43-1.49). Of the randomized patients, 81% had testosterone recovery in the AAPL group compared with 95% in the observation group, with a median time to recovery of <12 months in both arms.
CONCLUSIONS: In this study, because 30% of patients declined adjuvant treatment, part B was underpowered to detect differences between arms. Future perioperative studies should be biomarker-directed and include strategies for investigator and patient engagement to ensure compliance with protocol procedures.

OBJECTIVE: To obtain evidence of the clinical validity of the nursing diagnosis (ND) risk for disturbed maternal-fetal dyad in high-risk pregnancy.
METHODS: Causal validation of the ND through a case-control study performed in a university hospital with 155 high-risk pregnant women: 31 cases and 124 controls. A causal association was found between the ND etiological factors and the occurrence of disruption of the symbiotic maternal-fetal dyad; an association was verified when the etiological factor presented a p-value <0.05 and odds ratio >1.
RESULTS: The risk factor absent-inadequate prenatal care; populations at risk, such as young-advanced maternal age and economically disadvantaged pregnant women; and association conditions, such as maternal conditions and compromised fetal oxygen transport, increased the outcome likelihood. The associated condition maternal illnesses appeared as a protective factor.
CONCLUSIONS: Evidence of clinical validity of the ND risk for disturbed maternal-fetal dyad was obtained, and an association between etiological factors and disruption of the symbiotic maternal-fetal dyad was found.
CONCLUSIONS: The results contribute to advance scientific knowledge in nursing teaching, research, and practice and support the nursing process in high-risk pregnancies.

UNASSIGNED: Studies regarding the risk factors of prenatal anxiety disorders are inconclusive and sometimes contradictory. The current study aimed to define the prevalence and risk factors for anxiety disorders in women during pregnancy.
UNASSIGNED: This is a cross-sectional and hospital-based survey of two public hospitals (Ayatollah Rohani and Yahyanejad) of inpatients/outpatients, obstetric wards/clinics, and four private outpatient obstetric clinics in the city of Babol. Convenience sampling was utilized to recruit 432 pregnant women. A trained clinical psychologist conducted the Structured Clinical Interview for DSM-5 (SCID-5) to diagnose anxiety disorders. In addition, the Brief Symptom Inventory 18 (BSI-18) was completed by the participants to assess the severity of psychological distress.
UNASSIGNED: Of 432 pregnant women, 132 (30.5%) were diagnosed with anxiety disorders. Anxiety disorders included 61 cases of pregnancy adjustment disorder (47.7%), 52 cases of generalized anxiety disorder (40.6%), and 15 cases of specific phobia (to delivery) (11.7%). The logistic regression results showed that the age, pregnancy, education, parity, and high-risk pregnancy variables predicted 28% of the variance of anxiety disorders. Furthermore, as the age (β = 0.94, p = 0.003) and gestational age (β = 0.9, p < 0.001) increased, the probability of anxiety disorders in pregnancy decreased. Moreover, university education (β = 1.65, p = 0.049) and high-risk pregnancy (β = 1.72, p = 0.02) were recognized as risk factors for developing anxiety disorders during pregnancy.
UNASSIGNED: The high incidence of anxiety disorders in pregnant women suggests that obstetricians should pay more attention to identifying and treating anxiety disorders in all pregnant women, especially in high-risk pregnancies.