(UroToday.com) The 2023 European Society of Medical Oncology (ESMO) Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a prostate cancer abstracts poster session. Dr. Gabriela Ilie presented the results of a secondary analysis of the Prostate Cancer Patient Empowerment Program (PC-PEP) study, which evaluated the quality of life, physical fitness, and urinary function outcomes among prostate cancer patients with localized disease undergoing a comprehensive, daily six-month home-based program.
Dr. Ilie and colleagues had recently published the results of the primary analysis of PC-PEP in European Urology. In brief, this is a crossover randomized clinical trial of 128 men aged 50 to 82 years, who were scheduled for curative prostate cancer surgery or radiotherapy (with or without concurrent hormone therapy). Sixty-six patients received the 6 months PC-PEP intervention, with an additional 62 randomized to a waitlist-control of standard of care for 6 months followed by PC-PEP to the end of the year. PC-PEP comprises regular physical strength and pelvic floor muscle training, daily dietary advice, bio-feedback stress reduction, and social networking. The primary outcome was non-specific psychological distress (clinical cut-off ≥20) measured at baseline, and at 6 and 12 months using the Kessler Psychological Distress Scale (K10). This trial demonstrated that at 6 months, patients in the waitlist-control group had 3.59-fold increased odds for non-specific psychological distress and need for psychological treatment compared to men who received the PC-PEP intervention. At 12 months, the wait-list control group that received the intervention at 6 months had higher psychological distress than the early group.1
In this secondary analysis the authors investigated quality of life, physical fitness, and urinary function outcomes using weekly online compliance surveys, the International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite (EPIC), and SF-12. These were evaluated at baseline, 6 months, and 12 months, with mixed-effects linear models used to account for repeated measures analysis among the same individuals over serial time points.
The baseline patient characteristics and clinical outcomes were well-balanced between the two arms:
The weekly compliance was noted to be equally high among both groups. At 6 months, compared to the control group, the PC-PEP group had improved:
- IPSS bother score (p=0.004)
- EPIC urinary incontinence score (p=0.001)
- EPIC irritative/obstructive score (p=0.008)
- Physical fitness with lower BMI (p=0.001)
- SF-12 physical (p=0.002) and mental health (p=0.003) functions
Analyses revealed that providing the intervention early or late was equally beneficial to patients. Based on these results, the authors concluded that PC-PEP significantly improves lower urinary tract symptoms, physical function, and overall quality of life among men scheduled for curative prostate cancer treatment, compared to standard of care. The program is being currently tested in an international phase 4 trial.
Presented by: Gabriela Ilie, MD, PhD, Associate Professor, DMRF Endowed Soillse Research Scientist in Prostate Cancer Quality of Life Research, Dalhousie University, Halifax, Nova Scotia, Canada
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 European Society of Medical Oncology (ESMO) Annual Congress held in Madrid, Spain between October 20th and 24th, 2023
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