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Challenges and Solutions during the COVID Pandemic for Patient Retention and Physician Engagement in the Phase 3 ATLAS Study of Apalutamide Added to Androgen Deprivation Therapy (ADT) in High-Risk Localized or Locally Advanced Prostate Cancer (HRLPC)

https://doi.org/10.1016/j.ijrobp.2022.07.1217Get rights and content

Purpose/Objective(s)

The phase 3 ATLAS study (NCT02531516) is investigating if treatment intensification with apalutamide (APA) to neoadjuvant and adjuvant treatment with gonadotropin-releasing hormone agonist (GnRHa) and external beam radiation therapy (EBRT) improves metastasis-free survival (MFS) in high-risk patients (pts). To determine MFS improvement, long-term patient retention and physician engagement are critical. Here, we describe initiatives used for pt and physician participation, noting specific challenges related to pt retention during the COVID-19 pandemic, while maintaining trial integrity.

Materials/Methods

Eligible HRLPC pts (Gleason score [GS] ≥ 8 or 7; if GS 7, prostate-specific antigen ≥ 20 ng/mL; stage ≥ cT2c; ECOG PS 0/1; Charlson Comorbidity Index ≤ 3) stratified to GS, pelvic nodal status, use of brachytherapy boost, and region were randomized 1:1 to APA or placebo (PBO) plus GnRHa for 30 (28 d) treatment cycles. Treatment was applied neoadjuvant/concurrent to EBRT with APA 240 mg/d vs bicalutamide 50 mg/d for 4 cycles; 26 cycles are completed adjuvantly post EBRT with APA 240 mg/d vs PBO. To maximize pt retention to MFS primary end point, especially considering impact of the COVID-19 pandemic, retention initiatives that can be chosen by sites per local regulation are: reimbursing travel expenses, arranging travel for appointments, visiting nurse appointments for treatment management, using local labs and onsite radiology to reduce travel, using third-party vendors to maintain contact information, and regular pt newsletters. To support consistent physician engagement, initiatives include materials on pt retention, site newsletters, teleconferences on reducing pt engagement barriers, and training on study updates.

Results

Pts (N = 1503) were randomized at 266 sites in 24 countries (North America, Latin America, Europe, Asia). The study is ongoing. For patient retention, most sites (95%) are participating in travel reimbursement, coordination with local labs and onsite radiology, and pt newsletters; other program participation is varied. For physician engagement, all sites are receiving materials to retain pts and site newsletters. As of January 2022, 96% of patients remaining eligible for follow-up have been retained on the study. With the retention initiatives implemented, the overall dropout rate can be maintained below the expected and statistically acceptable limits.

Conclusion

Despite the COVID-19 pandemic, very low dropout rates have been observed. These initiatives have resulted in high levels of patient retention and physician engagement post treatment and aid in understanding how to enhance long-term clinical trial outcomes.

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