Once-Yearly Histrelin Subdermal Implant Provides Long-Term Efficacy In Prostate Cancer Patients

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Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology
Article Date: 20 Apr 2010 - 9:00 PDT


BARCELONA - The luteinizing hormone- releasing hormone (LHRH) agonist histrelin acetate (VantasR), a subcutaneous implant replaced once yearly, maintains testosterone suppression over four years of follow-up in men with advanced prostate cancer with no testosterone breakthrough, new data show.

The findings were reported at the 25th Anniversary European Association of Urology (EAU) Congress.

Histrelin acetate is a 50 mg implant that is surgically inserted in the inner aspect of the upper nondominant arm under local anesthesia and is replaced annually.

Dr. Neal Shore, Medical Director of Carolina Urologic Research Center/ Atlantic Urology Clinics in Myrtle Beach, South Carolina, reported data from an extension trial with histrelin implant.

The extension trial included 138 men who were enrolled in the histrelin arm in the original 52-week phase III registration study and had achieved the primary endpoint of testosterone suppression at four weeks.

Patients who entered the extension trial received a total of 305 implants: 94 during the extension phase and 211 patients during the main study.

An average of three implants was inserted in each patient over the course of the extension trial.

Serum testosterone remained suppressed below chemical castration levels (less than 50 ng/dl) throughout the extension period in all patients irrespective of the length of extension.

The insertion and removal procedures were performed rapidly and without difficulty. The adverse event profile was comparable to that expected for patients with advanced prostate cancer on androgen deprivation therapy.

"The study is important because it shows that a once-yearly treatment can safely provide ongoing efficacy in prostate cancer patients," Francois Desgrandchamps, MD, Director of the Urology Service at Hopital Saint Louis in Paris, France, said.

He also cited the results of a recent survey of prostate cancer patients in the UK and France which found that most patients feel that quality of life is more important than effective disease management. Notably, men said that the less often they are minded of their disease, the better. "Thus, an LHRH agonist that can be replaced once yearly will be more readily welcomed by patients than injections that need to be repeated at more frequent intervals," he said.

Prostate cancer is a highly prevalent disease with more than 670,000 new cases diagnosed each year worldwide.

Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.
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