Androgen deprivation therapy for volume reduction, lower urinary tract symptom relief and quality of life improvement in patients with prostate cancer: degarelix vs goserelin plus bicalutamide

Abstract

Study Type – Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Androgen deprivation therapy (ADT) is commonly used as a primary treatment for patients with prostate cancer (PCa) who are not eligible for radical treatment options. ADT is also used in patients with PCa as neo‐adjuvant hormone therapy to reduce prostate volume and down‐stage the disease before radiotherapy with curative intent. The present study showed that ADT with the gonadotropin hormone‐releasing hormone (GhRH) antagonist degarelix is non‐inferior to combined treatment with the LHRH agonist goserelin and bicalutamide in terms of reducing prostate volume during the treatment period of 3 months. Degarelix treatment evokes, however, significantly better relief of lower urinary tract symptoms in patients having moderate and severe voiding problems. OBJECTIVE To assess the efficacy of monthly degarelix treatment for reduction of total prostate volume (TPV), relief of lower urinary tract symptoms (LUTS) and improvement of quality of life (QoL) in patients with prostate cancer (PCa) using monthly goserelin as active control. METHODS This was a randomized, parallel‐arm, active‐controlled, open‐label, multicentre trial on 182 patients treated with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks. For flare protection, goserelin‐treated patients also received daily bicalutamide (50 mg) during the initial 28 days. Key trial variables monitored monthly were TPV (primary endpoint), serum testosterone, prostate‐specific antigen (PSA), the International Prostate Symptom Score (IPSS) and the Benign Prostate Hyperplasia Impact Index. RESULTS In all, 175 patients completed the trial (96.1%). At week 12, changes in TPV for degarelix and goserelin were similar (−37.2% vs −39.0%) and met the predefined non‐inferiority criterion. Decreases in IPSS were greater in degarelix than in goserelin‐treated patients, differences being statistically significant in patients with baseline IPSS > 13 (−6.7 ± 1.8 vs −4.0 ± 1.0; P= 0.02). The number of patients with an IPSS change of ≥3 over baseline was also significantly higher in patients treated with degarelix (61.0 vs 44.3%, P= 0.02). Both treatments were safe and well tolerated. CONCLUSIONS Medical castration reduces TPV and could also improve LUTS in patients with PCa. While the short‐term efficacy of degarelix and goserelin + bicalutamide was the same in terms of TPV reduction, degarelix showed superiority in LUTS relief in symptomatic patients, which could highlight the different actions of these drugs on extrapituitary gonadotrophin‐releasing hormone (GnRH) receptors in the bladder and/or the prostate.

Degarelix versus Goserelin plus Bicalutamide Therapy for Lower Urinary Tract Symptom Relief, Prostate Volume Reduction and Quality of Life Improvement in Men with Prostate Cancer: A Systematic Review and Meta-Analysis

“…One article lacked useful data (the values of IPSS, TPV and QoL). In total, three articles [11,12,13] with three RCTs were included in the analysis to compare degarelix with goserelin plus bicalutamide over 12 weeks. The baseline characteristics of the studies and patients included in our meta-analysis are listed in tables 1 and 2.…”

Investigation on lower urinary tract symptoms (LUTS) in elderly patients with prostate cancer (PC) received endocrine therapy

“…However, the clinical manifestations of aging bladder is often overshadowed by the symptoms resulted from BPH, so the occurrence of aging bladder in the elderly population is unclear. As reported previously, medical castration can reduce TPV and thus improve LUTS in patients with PC (Axcrona et al, 2012) we consider that LUTS unimproved after endocrine therapy might at least partly result from changes of bladder. Thus, we conducted this investigation on the LUTS presented during the endocrine therapy in patients with PC to explore whether aging bladder involves in the development of LUTS.…”

Modalités de castration dans la prise en charge du cancer de la prostate : sont-elles toutes équivalentes ?

“…En analysant les données d'un essai prospectif randomisé comparant antagoniste et agoniste pendant 3 mois, Axcrona et al n'ont pas constaté de différence significative en termes de réduction du volume prostatique [36]. En revanche, le score IPSS était amélioré en cas de traitement par antagoniste.…”