(UroToday.com) The 2023 ASTRO annual meeting included a session on patient-reported quality of life in prostate cancer, featuring a presentation by Dr. Atsunori Yorozu discussing health-related quality of life at five years for a randomized trial of tri-modality therapy with I-125 brachytherapy, external beam radiation therapy, and short- versus long-term androgen deprivation. Given that both arms have previously demonstrated similar efficacy and safety, the objective of the presentation at ASTRO 2023 was to describe the patient-reported health-related quality of life outcomes at five years from the TRIP/TRIGU0907 trial.
A total of 332 men with high-risk prostate cancer were randomized to either 6 months of ADT (n = 165) or 30 months of ADT (n = 167) in conjunction with combined modality radiation therapy. The trial design for TRIP is as follows:
For the health-related quality of life assessment, general health-related quality of life and disease-specific health-related quality of life were measured using the Japanese version of the Medical Outcomes Study 8-items Short-Form Health Survey (SF-8) and the Expanded Prostate Cancer Index Composite (EPIC). Patient-reported outcome questionnaires were filled out before ADT initiation (n = 215), and five years after (n = 213). Quality of life end points were assessed as the change between pre and post-treatment using the paired student t-test. Changes in the International Prostate Symptom Scores (IPSS) score, including total score and subscores, were also evaluated. Of note, the dose-volume parameters between groups were well balanced:
The study was powered according to the primary endpoint of biochemical progression free survival with health-related quality of life as a secondary endpoint. In addition, recovery of testosterone level (300ng/dL or higher) was calculated as the cumulative incidence curve and compared between arms by log-rank test. The cumulative incidence of biochemical progression, and salvage ADT treatment were not different between the arms. Mean domain scores at baseline were well balanced between the two arms in all health-related quality of life. There were no differences in the SF-8 assessment between the two arms at 5 years:
Similarly, there was no difference between arms for the total and subscore EPIC assessments:
The average sexual function score was lower in short arm versus long arm; 16.2 versus 20.2 at baseline, but not different at five years, 10.0 versus 7.8 (p = 0.16). Furthermore, there were no significant differences between the arms for the total and subscore IPSS:
Finally, there was a significantly higher percentage of patients in the short arm (71.7%) that recovered to a normal testosterone level at 6 years after the initiation of ADT compared to 43.2% in long arm (p<0.0001):
Dr. Yorozu concluded his presentation discussing health-related quality of life at five years for a randomized trial of tri-modality therapy with I-125 brachytherapy, external beam radiation therapy, and short- versus long-term androgen deprivation with the following take-home messages:
- For patients with high risk prostate cancer treated with a brachytherapy boost, 2 years of adjuvant ADT did not affect health related quality of life at 5 years, although it markedly reduced the recovery of testosterone and endocrine-related symptoms compared with 6 months of ADT
- The TRIP trial hypothesized that long-term ADT would benefit patients receiving a brachytherapy boost, however the results were negative
- A non-inferiority study including health related quality of life at 2 years should be considered to provide more conclusive evidence supporting these preliminary results
Presented by: Atsunori Yorozu, MD, PhD, National Hospital Organization Tokyo Medical Center, Tokyo, Japan
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2023 American Society for Therapeutic Radiation Oncology (ASTRO) 65th Annual Meeting held in San Diego, CA between October 1st and 4th, 2023