A pilot study: Utilization of PROMs in hypo-fractionated radiotherapy for localized prostate cancer.

Purpose/Objective: Patient Reported Outcome Measures (PROMS) are a useful metric in evidence-based clinical care and translational research. Recording treatment toxicities and Quality of Life (QoL) scores can provide useful information in counselling future patients to aid decision-making and inform consent. Real time PROMS have the ability to improve patient care and guide changes to therapy. Curative treatment options for prostate cancer (PCa) include prostatectomy, brachytherapy, external beam radiotherapy (EBRT) and combination therapy utilising EBRT followed by High Dose Rate Brachytherapy (HDR-BT). There is limited published evidence comparing PROMS for modern day radiotherapy techniques .This prospective study tested the feasibility of collecting multiple PROMS from PCa patients comparing HDR-BT combined with hypo-fractionated EBRT (hEBRT) (Combination Group) and hEBRT alone (Monotherapy Group).
Methods: Between June and August 2017, 20 men with localised PCa with confirmed treatment regimen, consented to participate. Ten patients received combination therapy (37.5Gy/15f + 15Gy HDR implant) and ten received hEBRT (60Gy/20f). Urinary, bowel, sexual, hormone problems and QoL were examined before, during and after treatment, using validated PROMS questionnaire methods and analysed as specified by developers. The results presented using descriptive statistics including the Mann-Whitney U test to test statistical significance.
Results: All participants completed treatment without interruption with 100% response rate to PROMs. SF-12 assessed QoL and results are summarised.
International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite-26 (EPIC-26) assessed treatment-related symptoms. IIEF-5 demonstrated severe erectile dysfunction (ED) occurrence at baseline at 20% this increased to 80% at Week 12 within both groups. All men reported some ED symptoms at Week 12. IPSS results showed a significant difference at the end of hEBRT; Combination (M=12, SD=4.58) and Monotherapy (M=20.5, SD=9.97); p=0.041. EPIC-26 results are presented.
Final fraction of hEBRT bowel summary demonstrated a clinically relevant difference and statistically significant difference; Combination (M=85.42, SD=18.01) and Monotherapy (M=64.59, SD=25.89); p=0.03 this remained at Week 12 (p=0.005).
Conclusion: This small study showed excellent patient compliance with completion of PROMS. Both treatment groups tolerated treatment well and there was minimal impact on QoL. In relation to treatment-related symptoms, the monotherapy group reported a higher incidence of bowel toxicity compared to the combination group. The feasibility of collecting multiple PROMS is evidenced in this study, streamlining of these tools into integrated technology applications and real time PROMS measurement has the ability to benefit patients and guide clinicians in adapting therapies based on individual need.