Background: The prophylactic administration of tranexamic acid has been shown to be appropriate for procedures with a high risk of perioperative bleeding in cardiac surgery and orthopaedics. In urology the ambiguous results have been reported. Our goal was to evaluate the effect of tranexamic acid administration in robotic-assisted radical prostatectomy (RARP). A pilot, prospective, double-blind, randomized study was conducted to evaluate this effect. Methods: The study included 100 patients who received RARP in the period from April 2017 to January 2018. The patients were randomly assigned to study and control groups of 50 patients each. Results: The median follow-up was 6 months. Lower haemoglobin level drop weighted for gram of operated prostate was observed in the study group when treating the dorsal vein complex (DVC) at the beginning of the procedure (p = 0.004 after 3 hours and p < 0.001 after 24 hours). There was no evidence of any serious side effect of tranexamic acid. Conclusion: We demonstrated the safety of tranexamic acid at RARP. In addition, we showed that administration of tranexamic acid at the beginning of RARP significantly reduces the decrease in haemoglobin after the procedure when treating the DVC at the beginning of the procedure.
PURPOSE Metastatic castration-resistant prostate cancer (mCRPC) remains a lethal disease with current standard-of-care therapies. Homologous recombination repair (HRR) gene alterations, including BRCA1/2 alterations, can sensitize cancer cells to poly (ADP-ribose) polymerase inhibition, which may improve outcomes in treatment-naïve mCRPC when combined with androgen receptor signaling inhibition. METHODS MAGNITUDE (ClinicalTrials.gov identifier: NCT03748641 ) is a phase III, randomized, double-blinded study that evaluates niraparib and abiraterone acetate plus prednisone (niraparib + AAP) in patients with (HRR+, n = 423) or without (HRR−, n = 247) HRR-associated gene alterations, as prospectively determined by tissue/plasma-based assays. Patients were assigned 1:1 to receive niraparib + AAP or placebo + AAP. The primary end point, radiographic progression-free survival (rPFS) assessed by central review, was evaluated first in the BRCA1/2 subgroup and then in the full HRR+ cohort, with secondary end points analyzed for the full HRR+ cohort if rPFS was statistically significant. A futility analysis was preplanned in the HRR− cohort. RESULTS Median rPFS in the BRCA1/2 subgroup was significantly longer in the niraparib + AAP group compared with the placebo + AAP group (16.6 v 10.9 months; hazard ratio [HR], 0.53; 95% CI, 0.36 to 0.79; P = .001). In the overall HRR+ cohort, rPFS was significantly longer in the niraparib + AAP group compared with the placebo + AAP group (16.5 v 13.7 months; HR, 0.73; 95% CI, 0.56 to 0.96; P = .022). These findings were supported by improvement in the secondary end points of time to symptomatic progression and time to initiation of cytotoxic chemotherapy. In the HRR− cohort, futility was declared per the prespecified criteria. Treatment with niraparib + AAP was tolerable, with anemia and hypertension as the most reported grade ≥ 3 adverse events. CONCLUSION Combination treatment with niraparib + AAP significantly lengthened rPFS in patients with HRR+ mCRPC compared with standard-of-care AAP.
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