Prostate Cancer Drug Trial Protocol Has Been Expanded
Researchers modified the study design to reach more patients with rising PSA levels after standard hormone therapies.
Updated on Oct. 6, 2026 in Cancer
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Kairos Pharma has expanded the Phase 2 trial protocol for its experimental drug, ENV-105, which targets castration-resistant prostate cancer. The update includes patients who have experienced increasing PSA levels despite receiving prior androgen signaling inhibitor treatments.
Why it matters
Modifying the study design aims to facilitate enrollment and broaden the population of men eligible for the trial, which tests a novel therapy for advanced prostate cancer. Expanding the eligibility criteria is intended to help researchers more effectively evaluate the drug's impact on treatment resistance.
In a 10-patient safety lead-in study, researchers observed a median progression-free survival of 17.7 months for ENV-105 combined with apalutamide, compared to 2 months for apalutamide monotherapy. These preliminary findings provided the basis for the trial expansion.
The players
Kairos Pharma
A biotechnology company developing oncology therapeutics that target mechanisms involved in treatment-resistant cancers.
Cedars-Sinai Medical Center
A prominent Los Angeles-based academic medical center that participates in clinical research and advanced oncological care.
The details
The experimental drug ENV-105 works by targeting the CD105 receptor, a protein that may play a role in tumor survival and progression in advanced prostate cancer. The study design will randomize 116 patients to compare the efficacy of the combination therapy—involving ENV-105 and Xtandi—against monotherapy. By targeting this specific receptor, investigators hope to overcome the treatment resistance that often occurs following androgen signaling inhibitor therapy.
Timeline
A physician at Cedars-Sinai Medical Center began the trial in 2023.
Researchers shared preliminary results from the 10-patient safety lead-in in September 2025.
Kairos Pharma reported $2.6 million in cash reserves as of June 2026.
The company aims to complete the Phase 2 trial by the fourth quarter of 2027.
Health Landscape
This trial addresses the significant challenge of managing castration-resistant prostate cancer, a condition that typically develops after standard androgen signaling inhibitor treatments fail. It sits within a broader research pipeline focused on developing novel agents that can effectively target treatment-resistant tumor cell pathways.
Patients currently managing prostate cancer with rising PSA levels should discuss whether clinical trials are appropriate for their treatment plan with their oncologist. Understanding eligibility for new protocols like this depends heavily on an individual's specific treatment history, including past use of hormone therapy agents.
The takeaway
The expansion of this trial reflects a targeted effort to improve outcomes for men whose prostate cancer no longer responds to standard hormone-blocking therapies. Patients and their families should regularly review their medical records to understand their PSA trends and discuss the implications of new clinical trials with their physician.
Further reading
For more information on the current standard of care and experimental approaches, visit the Cancer section.
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