SERM reduces ADT side effects

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 17 No 3
Volume 17
Issue 3

Toremifene citrate (Acapodene) 80 mg reduced the occurrence of vertebral fractures and met other key endpoints in a phase III trial of 1,389 men receiving androgen deprivation therapy for advanced prostate cancer, GTx, Inc. said in a press release. Based on these findings, the company plans to file a New Drug Application with FDA by the summer of this year for the treatment of multiple side effects of ADT.

MEMPHIS, Tennessee-Toremifene citrate (Acapodene) 80 mg reduced the occurrence of vertebral fractures and met other key endpoints in a phase III trial of 1,389 men receiving androgen deprivation therapy for advanced prostate cancer, GTx, Inc. said in a press release. Based on these findings, the company plans to file a New Drug Application with FDA by the summer of this year for the treatment of multiple side effects of ADT.

In an intent-to-treat analysis of the 2-year double-blind randomized study data, the selective estrogen-receptor modulator (SERM) reduced the occurrence of new morphometric vertebral fractures by 53%, compared with placebo (P = .034). Patients on the study drug also had significant increases in bone mineral density, decreased total cholesterol and triglyceride levels, increased HDL cholesterol levels, and significant improvements in gynecomastia. Full results will be presented at an upcoming medical meeting, the company said. 

Related Videos
Two women in genitourinary oncology discuss their experiences with figuring out when to begin a family and how to prioritize both work and children.
Over the past few decades, the prostate cancer space has evolved with increased funding for clinical trial creation and enrollment.
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Rohit Gosain, MD; Rahul Gosain, MD; and Rana R. McKay, MD, presenting slides
Anemia in patients who receive talazoparib plus enzalutamide for metastatic castration-resistant prostate cancer appears to be manageable without any compromises in patient-reported outcomes and quality of life.
Artificial intelligence models may be “seamlessly incorporated” into clinical workflow in the management of prostate cancer, says Eric Li, MD.
Robust genetic testing guidelines in the prostate cancer space must be supported by strong clinical research before they can be properly implemented, says William J. Catalona, MD.
Related Content