(apalutamide)
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ERLEADA® (apalutamide)
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ERLEADA - ATLAS Study
Last Updated: 06/07/2024
SUMMARY
- ATLAS (NCT02531516) is an ongoing phase 3, randomized, double-blind, placebocontrolled, multicenter study evaluating the efficacy and safety of adding ERLEADA to gonadotropin-releasing hormone agonist (GnRHa) and external beam radiation therapy (EBRT) in patients with high-risk localized or locally advanced prostate cancer. The primary endpoint is metastasis-free survival (MFS). Currently, the study is fully enrolled. Safety and efficacy results of the ATLAS study have not been published.1
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CLINICAL DATA
ATLAS is an ongoing study evaluating the efficacy and safety of adding ERLEADA to GnRHa and EBRT in patients with high-risk localized or locally advanced prostate cancer.1-3
Study Design/Methods
- Phase 3, randomized, double-blind, placebo-controlled, multicenter study.
- Currently, the study is fully enrolled.
- A total of 1503 patients were randomized 1:1 to receive the treatments described in Figure: ATLAS: Study Design during each 28-day treatment cycle.1-3
Abbreviations: BICR, blinded independent central review; CCI, Charlson Comorbidity Index; cT2c, clinical stage T2c; CYP17, cytochrome P450 17; ECOG PS, Eastern Cooperative Oncology Group performance status; EFS, event-free survival; GnRHa, gonadotropin-releasing hormone agonist; HRLPC, high-risk localized or locally advanced prostate cancer; MFS, metastasis-free survival; OS, overall survival; PBO, placebo; PET, positron emission tomography; PO, orally; PSA, prostate-specific antigen; QD, once daily; R, randomized; RT, radiation therapy.
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- Long-term follow-up will consist of monitoring prostate-specific antigen (PSA) and testosterone levels every 3 months until distant metastasis by blinded independent central review (BICR), conventional imaging every 6 months until distant metastasis by BICR or death, and positron emission tomography (PET) imaging every 6 months until distant metastasis on PET or conventional imaging by BICR or death.
- The collection of PET imaging data was added to the protocol to guide treatment of patients with biochemical failure (BCF) or progressive disease after definitive radiation therapy (RT) and hormonal therapy.
- The safety evaluation is based on periodic physical examination, vital signs, and laboratory tests at clinic visits.
- The effect of adding ERLEADA to GnRHa on symptoms, function, and health-related quality of life (HRQoL) will be evaluated via patient-reported outcomes (PROs).
Results
Patient Characteristics
- The demographics and baseline characteristics of all patients enrolled in the ATLAS study are described in Table: Select Patient Baseline Characteristics.
- A total of 90% of patients received standard EBRT to the prostate/pelvis over 68 weeks, while 10% and 6% of patients received hypofractionation and EBRT combined with brachytherapy, respectively.
- Patient retention and physician engagement strategies were initiated during the COVID-19 pandemic, and a 96% patient retention rate was observed.4
| Characteristic | Overall Population (N=1503) | |
|---|---|---|
| Mean age, years (SD) | 66.8 (6.7) | |
| Race, n (%) | ||
| White | 1130 (75) | |
| Asian | 137 (9) | |
| Black or African American | 86 (6) | |
| Other | 150 (10) | |
| Tumor stage at diagnosis, n (%) | ||
| T2c | 662 (44) | |
| T3 | 757 (50) | |
| T4 | 83 (6) | |
| Regional lymph node stage N1 at diagnosis, n (%) | 193 (13) | |
| Gleason score, n (%) | ||
| ≥8 | 1065 (71) | |
| 7 | 438 (29) | |
| ECOG PS, n (%) | ||
| 0 | 1337 (89) | |
| 1 | 166 (11) | |
| CCI, n (%) | ||
| 0-1 | 169 (11) | |
| 2 | 583 (39) | |
| 3 | 747 (50) | |
| Mean PSA, ng/mL (SD) | 20.6 (43) | |
| Used systemic therapy prior to randomization, n (%)a | 692 (46) | |
| Mean time from diagnosis to randomization, months (SD) | 3.6 (3) | |
| Abbreviations: CCI, Charlson Comorbidity Index; ECOG PS, Eastern Cooperative Oncology Group performance status; GnRHa, gonadotropin-releasing hormone agonist; PSA, prostate-specific antigen; SD, standard deviation. aGnRHa could be started up to 3 months prior to treatment cycle 1. | ||
Literature Search
A literature search of MEDLINE®
References
| 1 | Sandler HM, Freedland SJ, Shore ND, et al. Patient (pt) population and radiation therapy (RT) type in the long-term phase 3 double-blind, placebo (PBO)-controlled ATLAS study of apalutamide (APA) added to androgen deprivation therapy (ADT) in high-risk localized or locally advanced prostate cancer (HRLPC). Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2022; Chicago, IL and online. |
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