Everolimus in Treating Patients With Newly Diagnosed Localized Prostate Cancer

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving everolimus before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying the side effects and how well everolimus works in treating patients with newly diagnosed localized prostate cancer.

Timeline

Start

2007-09

Primary completion

2011-07

Completion

2011-08

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow accrual”

paper Neoadjuvant everolimus given at 5 mg or 10 mg daily for 8 weeks prior to radical prostatectomy did not impact pathologic responses and surgical outcomes of patients with high-risk prostate cancer. PMID 31037562 ↗

Publications

• Koshkin VS, Mir MC, Barata P, Gul A, Gupta R, Stephenson AJ, Kaouk J, Berglund R, Magi-Galluzzi C, Klein EA, Dreicer R, Garcia JA. Randomized phase II trial of neoadjuvant everolimus in patients with high-risk localized prostate cancer. Invest New Drugs. 2019 Jun;37(3):559-566. doi: 10.1007/s10637-019-00778-4. Epub 2019 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	5 mg	Oral
Subject	Everolimus	Small molecule	10 mg	Oral

Indications