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.
Prolaris in Practice: Guiding ADT Benefits, Clinical Application, and Expert Insights From ACRO 2025
April 15th 2025Steven E. Finkelstein, MD, DABR, FACRO discuses how Prolaris distinguishes itself from other genomic biomarker platforms by providing uniquely actionable clinical information that quantifies the absolute benefit of androgen deprivation therapy when added to radiation therapy, offering clinicians a more precise tool for personalizing prostate cancer treatment strategies.
CCR Scores and Beyond: Precision Strategies for Treatment Intensification in Prostate Cancer
April 15th 2025Alvaro Martinez, MD discusses how emerging genomic risk stratification tools such as the clinical cell-cycle risk (CCR) score are transforming personalized prostate cancer treatment by enabling more nuanced assessments of metastasis risk and treatment intensification strategies beyond traditional NCCN risk groupings.