Clinical Trial Overview
Investigators at the UCLA Health Jonsson Comprehensive Cancer Center have initiated a Phase 2 clinical trial, named ANDROMEDA, to evaluate a combined treatment approach for recurrent prostate cancer. The trial aims to determine if precision radiation combined with targeted radioactive therapy can delay cancer progression and mitigate the side effects associated with long-term hormone therapy.
Treatment Comparison
The ANDROMEDA trial is designed to directly compare two distinct PSMA-targeted radiopharmaceuticals: lutetium-177–PSMA-617 and actinium-225–PSMA-617. These therapies are administered alongside stereotactic body radiotherapy (SBRT), a focused radiation method targeting all detectable tumors.
PSMA (prostate-specific membrane antigen) is a protein commonly found on prostate cancer cells, making it a suitable target for direct radiation delivery to cancer cells while minimizing impact on healthy surrounding tissue. Lutetium-177 emits beta particles, characterized by a longer travel distance and lower energy. In contrast, actinium-225 emits alpha particles, which are more potent and provide a highly localized radiation dose.
Leadership and Rationale
The trial is co-led by Dr. Amar Kishan, professor and executive vice chair of radiation oncology, and Dr. Jeremie Calais, director of the Nuclear Medicine and Theranostics' clinical research program. Researchers hypothesize that actinium-225 may offer greater effectiveness in targeting microscopic disease compared to lutetium-177. This hypothesis is based on prior research, including the LUNAR trial, which indicated that adding lutetium-177-based therapy to SBRT could extend progression-free survival in recurrent prostate cancer.
Patient Enrollment and Protocol
The trial is actively enrolling men diagnosed with oligorecurrent prostate cancer, defined as cancer that has reappeared in one to five distinct locations, as identified by a PSMA PET scan. Participants will receive radiation directed at all detectable tumors. This will be followed by either two cycles of lutetium-177-based therapy or a single cycle of actinium-225-based therapy, prior to receiving SBRT.
Patient progress will be monitored through follow-up imaging, blood tests, and assessments of patient-reported quality-of-life measures.
Anticipated Outcomes
The primary goal of combining these therapies is to delay or potentially avert the need for hormone therapy, which often leads to side effects such as fatigue, hot flashes, and bone loss. Researchers aim to eliminate both visible tumors and microscopic disease, thereby improving long-term cancer control while maintaining a higher quality of life for patients.