The impact of GnRH (gonadotropin-releasing hormone) therapy on comorbidities and lifestyle is complex but important to consider in men with PCa. The LEAN study aims to analyse associations between various anamnestic factors and PSA dynamics in men with advanced, hormone-dependent PCa receiving a leuprorelin acetate solid implant (Leuprorelin Sandoz®/Leuprone® HEXAL®).
Patients were enrolled at 190 German centres from January 2014. Metabolic data, body measures, PSA and testosterone were assessed at baseline and during 1-year follow-up. Cox model analyses assessed associations between anamnestic factors and PSA progression. Data are presented as mean±standard deviations.
A total of 959 patients have been recruited. Median patient age was 75 years (range 50–93; ≥65: 90%) and median body mass index (BMI) was 28 kg/m2 (range: 18–49; >30: 22%). Primary diagnosis of PCa was 26±47 months before inclusion, with PSA levels of 32±53 ng/mL [median: 11] and serum testosterone of 3.6±2.16 ng/mL [median: 3.5]. Six of the 12 (median) core biopsies were positive at primary diagnosis, with a Gleason Score of 7.5±1.2 (median: 7). A total of 189 patients (27%) had previous radical prostatectomy 29±50 days (median: 7) before inclusion. Over 50% of patients had concomitant cardiovascular disease and 16% had disorders of glucose or lipid metabolism. At 3, 6, 9 and 12 months after the start of leuprorelin therapy, median PSA values decreased to 0.6, 0.3, 0.2 and 0.2 ng/mL, respectively, and median testosterone levels were 0.2, 0.2, 0.2 and 0.2 ng/mL. PSA progression occurred in 168 patients: in 28% of patients with BMI ≤30 and in 26% with BMI >30, indicating no clear association with BMI (p = 0.7427). Cox model analyses also showed no clear influence on PSA progression of other anamnestic factors.
Patients in the LEAN study represent a real-life population receiving therapy with a GnRH agonist. Results show no clear influence of anamnestic factors on PSA progression.
Clinical trial identification
Legal entity responsible for the study
This study was funded by Hexal AG/Sandoz International GmbH.
B. Schmitz-Dräger: Consultant or assessor: Hexal, Janssen, Amgen Fees: Hexal, Janssen, Myriad, Astellas. S. Mühlich: Consultant or assessor: Hexal Fees: Hexal, Janssen, Medac. B. Ottillinger: Consultant or assessor: Hexal Fees: Hexal Employment or position of leadership: Hexal. M. Studen: Holder of shares, stocks or funds: Hexal, Amgen Employment or position of leadership: Hexal.