CHICAGO, IL USA (UroToday.com) - Along with evidence of the long-term efficacy and safely of a novel oral androgen receptor -- ODM-201 – details of the launch of a phase 3 study, now open and recruiting, were presented at the 2015 ASCO Annual Meeting, in Chicago, IL. The large study aims to address a major unmet need, namely preventing metastatic disease in men with high-risk non-metastatic castrate-resistant prostate cancer (nmCRPC).
“Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer—ARAMIS—is a randomized, double-blind, placebo-controlled, trial in more than 30 countries. A total of 1 500 patients on androgen deprivation therapy (ADT) will be enrolled. Patients will be stratified by PSADT and baseline use of a bone-targeting agent.
Eligibility criteria include a diagnosis of nmCRPC, PSADT ≤ 10 months and screening PSA ≥ 2 ng/mL. The primary endpoint of ARAMIS is metastasis-free survival based on central independent reviews of bone scans and CT/MRI every 16 weeks.
Secondary endpoints are overall survival, time to first skeletal event (SSE), initiation of first cytotoxic chemotherapy for prostate cancer, pain progression, and first use of opioids. Additional endpoints are progression-free survival, time to first prostate cancer-related invasive procedure, initiation of subsequent antineoplastic therapy, PSA progression, change in ECOG status, and changes in health-related QoL
Now open and recruiting, the ARAMIS trial enrolled its first patient October 2014.
- Massard C, Fizazi K, Bono P, et al. Long-term efficacy and safety of androgen receptor inhibitor OD-201 in ARADES phase I/II trial. 2015 ASCO Annual Meeting, Chicago, Il. Abstract 5079.
- Fizazi K, Shore ND, Teuvo L, et al. ARAMIS trial: Efficacy and safety phase 3 trial of ODM-201 in men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). ASCO 2015 Annual Meeting, Chicago, Il. Abstract TPS5080.
Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting - Illumination & Innovation: Transforming Data into Learning - May 29 - June 2, 2015 - Chicago, Illinois USA