New Alliance trial aims to improve outcomes in metastatic prostate cancer

The Alliance for Clinical Trials in Oncology has launched the ASPIRE trial—a large-scale, Phase III clinical study investigating whether adding chemotherapy to current standard treatments can extend survival for men living with advanced prostate cancer.

The ASPIRE trial (Alliance A032302) is enrolling 1,200 participants across the United States with metastatic castrate-sensitive prostate cancer (mCSPC). The study seeks to determine whether the addition of docetaxel, a well-established chemotherapy drug, to hormone therapy and apalutamide—a next-generation androgen receptor inhibitor that works to block testosterone growth—can improve overall survival in men newly diagnosed with mCSPC.

Prostate cancer remains one of the most common cancers among men with an estimated 1.5 million cases diagnosed worldwide. While hormone therapy has long been the cornerstone of treatment for metastatic disease, recent advances have introduced newer agents like apalutamide that target the androgen receptor more effectively. However, questions remain about whether combining these agents with chemotherapy can further improve outcomes.

"ASPIRE is designed to answer a critical question in prostate cancer care," said Deepak Kilari, MD, principal investigator for the trial and associate professor in the division of hematology and oncology at Froedtert and the Medical College of Wisconsin. "We want to know if intensifying treatment early—by adding the chemotherapy medication docetaxel—can help patients live longer and better."

Participants in the ASPIRE trial will be randomly assigned to one of two treatment arms:

• Standard Arm: Hormone therapy plus apalutamide.
• Intervention Arm: Hormone therapy plus apalutamide and docetaxel, administered intravenously every 21 days for up to six cycles.

The trial's primary endpoint is overall survival, but researchers are also evaluating secondary outcomes, including progression-free survival and quality of life. Importantly, the study includes genomic analysis to assess whether patients with mutations in TP53, PTEN or RB1—genes associated with more aggressive disease—derive greater benefit from the intensified treatment.

The ASPIRE trial is notable not only for its scale but also for its long-term follow-up. Patients will be monitored every six months for up to 10 years, allowing researchers to gather robust data on survival, disease progression and treatment-related side effects.

The inclusion of genetic profiling in the ASPIRE trial reflects a growing trend toward precision oncology, where treatments are tailored to the molecular characteristics of each patient's cancer. By identifying which subgroups benefit most from docetaxel, researchers hope to refine treatment strategies and avoid unnecessary toxicity in patients unlikely to benefit.

The ASPIRE study is being conducted by the Alliance for Clinical Trials in Oncology and supported by the National Cancer Institute (NCI) through the National Clinical Trials Network.

Provided by Alliance for Clinical Trials in Oncology