KEY TAKEAWAYS
- The Phase 3 study aimed to outline the patient retention and physician engagement strategies during COVID-19 in the ATLAS study of apalutamide added to androgen deprivation therapy in HRLPC.
- Minimal protocol deviations were seen in the ATLAS phase 3 study, even with COVID-19 challenges.
- The efforts resulted in strong patient and physician participation, emphasizing the key role of nurse leadership in trial coordination and education.
The ATLAS phase 3 trial assessed adding apalutamide to gonadotropin-releasing hormone agonist (GnRHa) and external beam radiation therapy (EBRT) on metastasis-free survival (MFS) for patients with high-risk localized or locally advanced prostate cancer (HRLPC).
This study outlined strategies for sustaining patient and physician involvement while addressing particular retention challenges during the COVID-19 pandemic and upholding trial integrity.
Qualifying HRLPC patients, based on various criteria, including Gleason score and PSA levels, were evenly divided into groups receiving either apalutamide or a placebo in addition to GnRHa for 30 treatment cycles. These treatments were either concurrent with or followed EBRT.
Currently, the study has reached full enrollment with 1,503 patients from 266 locations in 24 countries. The study’s patient population exhibited certain key characteristics, such as median age and tumor risk classification. To boost patient commitment until the main outcome (MFS) is determined, nearly all sites are offering travel reimbursement and other conveniences like local lab coordination and educational newsletters. For clinician involvement, resources are being distributed to all locations to facilitate patient retention.
The ATLAS phase 3 trial has observed minimal deviation from the planned schedule of events, even amidst the COVID-19 pandemic. These retention efforts have successfully maintained high levels of participation from patients and physicians, emphasizing the critical role of nursing leadership in ensuring trial adherence and education alongside sponsors and medical investigators.
Source: https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/13500
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02531516
Sutton, J., Shore, N.D., Mundle, S.D., Brookman-May, S.D., Feng, F. Patient retention and physician engagement strategies during the COVID-19 pandemic in the phase 3 ATLAS study of apalutamide added to androgen deprivation therapy in high-risk localized or locally advanced prostate cancer.
