2864 - Exploring Quality of Life, and Changes in Sexual Function and Urinary Symptoms in Patients Commencing Combined Hormonal Therapy with Abiraterone Acetate and a GnRH Agonist: A Prospective Study [CTRIAL

G. Murphy¹, I. Parker², M. Sheehan¹, P. Kelly³, C. Small⁴, and P. Thirion²; ¹St Lukes Radiation Oncology Network, Dublin, Ireland, ²Cancer Trials Ireland, Dublin, Ireland, ³UPMC Kildare Hospital, Clane, Kildare, Ireland, ⁴University Hospital Galway, Galway, Ireland

Purpose/Objective(s): To evaluate the impact of neoadjuvant (NA) combined hormonal therapy by abiraterone acetate (AA), prednisolone and a gonadotrophin releasing hormone (GnRH) agonist on patient-reported quality-of-life measures, sexual function, and urinary symptoms over a 4-month time period following initiation of therapy in patients with treatment-naïve high-risk localised prostate cancer (HRLPC). Materials/

Methods: A single-arm phase II clinical trial recruited 45 patients (pts) between 07/2015 and 02/2020. Eligible pts were diagnosed with RTOG HRLPC, planned for radical radiotherapy with an indication for adjuvant/concomitant hormonal therapy. Patients completed 4 months of pre-radiotherapy NA combined hormonal therapy by AA, prednisolone and GnRH agonist. Trial participants completed serial 1.) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE,v 4.0) for Androgen deprivation-related symptoms, 2.) International Prostate Symptom Scores (IPSS), 3.) International Index of Erectile Function (IIEF), prior to treatment and after 2 weeks, 6 weeks, 10 weeks, 14 weeks of treatment and upon completion of treatment after 4 months.
Results: 43 pts experienced a treatment emergent adverse event (TEAE). The most common TEAEs were hot flush [n=35, (77.8%)], fatigue [n=22, (48.9%)], alanine aminotransferase increase [n=20, (44.4%)], aspartate aminotransferase increase [n=20, (44.4%)] and hypertension [n=20, (44.4%)]. Less than half of pts [n=18 (40%)] experienced a Grade 3 TEAE. There were no Grade 4 or 5 TEAEs. Of the 20 pts with normal erectile function at baseline, the erectile dysfunction rate was 65% (n=13) at 2 weeks, 90% (n=18) at 6 weeks and 95% (n=19) at 4 months. Of 22 pts with normal orgasmic function at baseline, the anorgasmia rate was 50% (n=11) after 2 weeks, 95.5% (n=21) at 6 weeks and 100% (n=22) at 4 months. Of 23 pts with normal sexual desire at baseline, 12 (52.2%), 15 (65.2%) and 18 (78.3%) reported a decrease at 2 weeks, 6 weeks and 4 months respectively. Of 29 pts with normal overall satisfaction at baseline, 6 (20.7%), 8 (27.6%) and 13 (44.8%) reported a decrease in satisfaction at 2 weeks, 6 weeks and 4 months respectively. The median (min, max) total IPSS score at baseline was 9.0 (0, 32), with a max total score of 35. The median change from baseline was -1.0 (-30, -10) at the end of study treatment, which was observed from 14 weeks, indicating minimal change in symptoms.
Conclusion: TEAEs were universal in the present pt cohort, however the majority were Grade 1-2 in severity. Sexual function declines quickly within 2 weeks after initiation of combined hormonal therapy and is significant after 4 months with only 1 patient remaining sexually active at that time. Overall satisfaction showed a lesser but substantial decrease over time. Urinary symptoms did not significantly change over our study period. We hope this information will inform physicians counselling their pts prior to initiation of combined AA and GnRH therapy.