ATLAS Trial Confirms Radiotherapy Can Be Combined with Next-Gen Hormonal Therapy in Phase 3 Studies of HRLPC Treatments

Article

The radiotherapy schedules used in the ATLAS trial reflect recent evidence and guideline changes for its usage in patients with high-risk localized or locally advanced prostate cancer.

The fully enrolled phase 3 ATLAS trial (NCT02951052) proves that radiotherapy can be administered in phase 3 trials of patients with high-risk localized or locally advanced prostate cancer, according to updated baseline patient characteristics presented at the 2022 American Society of Clinical Oncology Annual Meeting.

“ATLAS is an example of how RT can be included in phase 3 trials of HRLPC in combination with next-generation hormonal therapy,” the study authors wrote in a poster of the study.

The current treatment approach for patients with high-risk localized or locally advanced prostate cancer (HRLPC) comprises androgen deprivation therapy (ADT) combined with radiotherapy (RT).

Although effective in some patients, ADT plus RT doesn’t significantly reduce the risk for metastases and death.

In the ATLAS trial, investigators are assessing if adding apalutamide (Erleada) to ADT (gonadotropin-releasing hormone agonist [GnRHa]) and external beam radiation therapy (EBRT) is feasible in patients with high-risk disease.

A total of 1,503 patients (median age, 67 years) are currently enrolled onto the trial. A total of 89% and 11% of patients have an ECOG PS of 0 or 1, respectively. In regard to tumor classification, 66% are high-risk and 34% are very high-risk. Median PSA is 6.3 ng/mL and cT2 in 44%, CT2 in 50% and cN1 in 13%.

“Baseline characteristics demonstrate high- and very higher-risk features of prostate cancer and pelvic nodal involvements in patients undergoing primary RT in clinical practice,” the researchers wrote.

In 90% of patients included in the study, RT use was standard EBRT to prostate/pelvis over 6-8 weeks (cumulative 78-81 GY); in 10% of patients recent hypofractionation schedules were applied, and 5.6% had EBRT combine with brachytherapy.

“The RT schedules applied reflect recent evidence and guideline changes for the use of hypofractionation in this patient population,” the researchers wrote.

Patients were randomized to APA or placebo plus GnRHa for 30 (28-d) treatment cycles. All patients received GnRHa and primary RT as standard of care. And the placebo group also received bicalutamide in the neoadjuvant setting, concurrent with RT.

The authors noted that the RT schedules in ATLAS mimic recent evidence and guideline changes for the use of hypofractionation in this group of patients.

Reference

Sandler H, Freedland S, Shore N, 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). J Clin Oncol. 2022; 40(suppl_16):5084. doi: 10.1200/JCO.2022.40.16_suppl.5084

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
Success with the 177Lu-PSMA-617 radioligand therapy would be transformative for the clear cell renal cell carcinoma treatment landscape.
An ongoing phase 1 trial seeks to prove XmAb819 as an effective treatment and ENPP3 as a plausible target in patients with relapsed or refractory RCC.
“The therapy is designed to prevent both CAR T-cell inactivation and to restore the anti-tumor immunity of the white blood cells that have gotten through the tumor,” said Marasco, MD, PhD.
Ongoing studies aim to combine base immunotherapy regimens with novel agents to potentially improve outcomes among patients with kidney cancer.
Investigators have found a way to reduce liver and biliary toxicity when targeting the molecule CAIX in patients with clear cell renal cell carcinoma.
Neoantigen-targeting vaccines resulted in an absence of recurrence in 9 patients with high-risk kidney cancer, according to David A. Braun, MD, PhD.
The Kidney Cancer Research Consortium may allow collaborators to form more mechanistic and scientifically driven efforts in the field.
Wayne A. Marasco, MD, PhD, stated that by targeting 2 molecules instead of 1, higher levels of tumor cell killing can be achieved in patients with clear cell renal cell carcinoma.
Leading experts in the breast cancer field highlight the use of CDK4/6 inhibitors, antibody-drug conjugates, and other treatment modalities.
Related Content