The Alliance for Clinical Trials in Oncology is now enrolling patients in the ASPIRE trial (A032302)-a large-scale, phase III clinical study investigating whether adding chemotherapy to current standard treatments extends survival for men with advanced prostate cancer.
"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-to the standard hormone therapy can help patients live longer and maintain a better quality of life."
"The genomic analysis built into ASPIRE is an important feature of the study. Examining TP53, PTEN, and RB1 alterations may help clarify which patients benefit most from treatment intensification and may inform more tailored approaches over time" said Rana McKay, MD, vice-chair of the Alliance Genitourinary Committee and professor of medicine, urology, and radiation medicine at the University of California San Diego.
Since the trial opened in October 2025, 177 cancer centers across the United States have begun offering the trial to patients. To date, 18 men at sites in Arizona, California, Kansas, Illinois, Montana, New Jersey, Pennsylvania and Washington, D.C., have joined the study. As part of the National Clinical Trials Network, the Alliance works with community cancer centers across the nation to ensure patients have access to life-changing trials, regardless of their proximity to an urban center or major research hospital.
The ASPIRE trial aims to ultimately enroll about 1,200 participants. The study is open to men 18 years of age or older with metastatic prostate cancer as confirmed by imaging studies.
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.
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 through the National Clinical Trials Network.
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