ASPIRE trial to evaluate triplet therapy for mCSPC

The Alliance for Clinical Trials in Oncology has announced the launch of the phase 3 ASPIRE trial (NCT06931340; Alliance A032302), assessing the effect of adding chemotherapy to treatment with hormone therapy and apalutamide (Erleada) in patients with metastatic castration-sensitive prostate cancer (mCSPC).¹

“ASPIRE is designed to answer a critical question in prostate cancer care,” explained 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, in a news release.¹ “We want to know if intensifying treatment early—by adding the chemotherapy medication docetaxel—can help patients live longer and better.”

In total, the open-label trial aims to enroll approximately 1200 adult participants with mCSPC through clinical trial sites across the US.² To be eligible for enrollment, patients must have evidence of metastatic disease and an ECOG performance score of 2 or lower. Patients may not have metachronous low-volume disease or prior exposure to chemotherapy for prostate cancer.

Participants in the study will be randomly assigned to receive treatment with androgen deprivation therapy (ADT) plus apalutamide (arm 1) or to ADT and apalutamide plus intravenous docetaxel administered every 21 days for up to 6 cycles (arm 2). Treatment cycles repeat every 12 weeks until disease progression or unacceptable toxicity. Patients in both study arms may choose to undergo PSMA-PET scans and blood sample collection throughout the study.

The primary end point for the study is overall survival (OS). Secondary outcome measures include radiographic progression-free survival (rPFS), objective response rate, time to castration-resistant prostate cancer, safety, and quality-of-life measures. The investigators will also assess OS and rPFS results stratified by gene alteration status to determine if patients with mutations in TP53, PTEN, or RB1 derive greater benefit from treatment intensification with docetaxel. 

According to the Alliance for Clinical Trials in Oncology: “By identifying which subgroups benefit most from docetaxel, researchers hope to refine treatment strategies and avoid unnecessary toxicity in patients unlikely to benefit.”¹

All patients in the study will be monitored every 6 months for 10 years. Primary completion of the study is expected in November 2031, with final completion slated for May 2039.

REFERENCES

1. New Alliance trial aims to improve outcomes in metastatic prostate cancer. News release. Alliance for Clinical Trials in Oncology. October 6, 2025. Accessed October 13, 2025. https://www.allianceforclinicaltrialsinoncology.org/main/public/news/archived.xhtml

2. Testing the addition of docetaxel (chemotherapy) to the usual treatment (hormonal therapy and apalutamide) for metastatic prostate cancer, ASPIRE trial. ClinicalTrials.gov. Updated April 17, 2025. Accessed October 13, 2025. https://clinicaltrials.gov/study/NCT06931340