Newswire (Published: Tuesday, March 17, 2020, Received: Tuesday, March 17, 2020, 7:20:03 PM CDT)

Word Count: 504

2020 MAR 17 (NewsRx) -- By a News Reporter-Staff News Editor at Chemicals & Chemistry Daily Daily -- Investigators discuss new findings in Oncology - Prostate Cancer. According to news reporting out of Myrtle Beach, South Carolina, by NewsRx editors, research stated, “To determine the safety, efficacy and pharmacokinetic (PK) profile of a pre-mixed depot formulation of leuprolide mesylate subcutaneous injectable suspension (LMIS) 50 mg for up to 1 year of treatment for subjects with advanced prostate cancer. In this open-label, multicenter study, prostate cancer patients with indication for androgen ablation therapy received two subcutaneous injection of LMIS 50 mg 6 months apart and were followed for an additional 6 months.”

Our news journalists obtained a quote from the research from Carolina Urologic Research Center, “Two efficacy primary end points were the percentage of subjects with a serum testosterone level <= 50 ng/dL by Day 28 as well as the percentage of subjects with similar testosterone suppression from Day 28 to Day 336. Of the 137 enrolled subjects, 15 (10.9%) subjects did not complete the study, including 5 subjects who terminated early due to an adverse event. By Day 28, 98.5% (95% confidence interval 94.8-99.8) of the subjects achieved a castrate testosterone level. At the end of the study, 97% and 95.9% of the subjects had serum testosterone level <= 50 ng/dL and <= 20 ng/dL, respectively. LMIS 50 mg significantly reduced serum prostate-specific antigen levels after its first injection and this PSA declination effect remained until the end of the study. No statistically significant change was observed in worsening bone pain or urinary symptom assessments during the study. Hot flush (48.9%) and hypertension (14.6%) were the two most common adverse events reported.”

According to the news editors, the research concluded: “LMIS 50 mg, administered at 6-month intervals, effectively suppressed serum testosterone level, and demonstrated a consistent safety profile.”

For more information on this research see: A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients. World Journal of Urology, 2020;38(1):111-119. World Journal of Urology can be contacted at: Springer, One New York Plaza, Suite 4600, New York, Ny, United States. (Springer - www.springer.com; World Journal of Urology - http://www.springerlink.com/content/0724-4983/)

Our news journalists report that additional information may be obtained by contacting N. Shore, Carolina Urologic Research Center, Suite B, 823 82ND Pkwy, Myrtle Beach, SC 29579, United States. Additional authors for this research include I. Mincik, M. DeGuenther, V. Student, M. Jievaltas, J. Patockova, K. Simpson, C.H. Hu, S.T. Huang, Y.H. Li, Y.S. Lee, B. Chien and J. Mao.

The direct object identifier (DOI) for that additional information is: https://doi.org/10.1007/s00345-019-02741-7. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.

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