757 ALKALINE PHOSPHATASE CONTROL AND PROSTATE VOLUME REDUCTION UNDER DEGARELIX TREATMENT IN PROSTATE CANCER PATIENTS CONFIRMED BY REAL LIFE DATA FROM A GERMAN REGISTRY

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced II1 Apr 2012757 ALKALINE PHOSPHATASE CONTROL AND PROSTATE VOLUME REDUCTION UNDER DEGARELIX TREATMENT IN PROSTATE CANCER PATIENTS CONFIRMED BY REAL LIFE DATA FROM A GERMAN REGISTRY Götz Geiges, Alexander Tolle, Matthias Schulze, and Michael Gedamke Götz GeigesGötz Geiges Berlin, Germany More articles by this author , Alexander TolleAlexander Tolle Kiel, Germany More articles by this author , Matthias SchulzeMatthias Schulze Berlin, Germany More articles by this author , and Michael GedamkeMichael Gedamke Kiel, Germany More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.844AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To date there is only limited data available on the efficacy and safety of degarelix in daily clinical practice. Also information on the clinical usage of degarelix is so far not published. In order to close this gap we collected data about the use of degarelix in routine daily practise in an uro-oncological registry. METHODS Data from 421 patients with prostate cancer treated with degarelix were collected by 93 office based urologists. Previous treatment, concomitant medication, tumour stage and grade as well as alkaline phosphatase (ALP), prostate volume, testosterone, PSA, and side-effects were documented over a period of up to 24 months or until completion of therapy. RESULTS Tumour stages were documented at baseline as T1 27.9%, T2 22.0%, T3 25.1%, T4 13.1% and Tx 11.5%. Distant skeletal metastases were seen in 24.3%, 35.8% were without distant metastases, the status was unknown in 39.9%. A Gleason-Score (GS) <7 was found in 20.1%, GS 7 in 33.2% and GS >7 in 43.7% of patients, in 3.0% GS was unknown. Median PSA at baseline was 12.4 ng/mL. Testosterone was above castration level (>0.5ng/mL) in 41.7% of patients with previous hormone therapy and available testosterone value at inclusion (n=48). The major side effects observed were hot flushes (8.8 %) and erythema at injection site (7.9 %). Interestingly frequency of pain and back pain at the last documentation was reduced by 20.9% and 58.8% respectively. PSA-reduction to <4 ng/mL after 12 month was achieved in 83.3% of patients with baseline-PSA <10 ng/mL also including patients with previous hormonal therapy. For patients in which ALP was measured (n=61), ALP was suppressed from a median of 639.9 (IU/L) to 108.7 (IU/L) after two month, and was still suppressed to 78.6 (IU/L) at month 12. Prostate volume measured by transrectal ultrasound was reduced by 40.8% within 3 months compared to baseline. CONCLUSIONS Efficacy and safety of treatment with degarelix was confirmed in routine daily practise. The efficacy of degarelix is comparable with other androgen-deprivation-therapies. The control of ALP by degarelix in daily clinical practice is in line with previously reported results from the pivotal trial. Also the prostate volume reduction of 40.8% was comparable with that found in a recent randomized clinical trial. Especially patients with high tumour burden or those scheduled for neoadjuvant hormone therapy prior to radiotherapy could benefit from the fast volume reduction offered by degarelix. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e309-e310 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Götz Geiges Berlin, Germany More articles by this author Alexander Tolle Kiel, Germany More articles by this author Matthias Schulze Berlin, Germany More articles by this author Michael Gedamke Kiel, Germany More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...