Dr. Jeremie Calais, director of the Ahmanson Translational Theranostics Division’s clinical research program and associate professor at the department of molecular and medical pharmacology at the David Geffen School at UCLA, has received two grants from Novartis totaling $4 million aimed at improving the effectiveness of the radiation-emitting targeted therapy 177-Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC), one of the most challenging forms of the disease.
The funding will help support two phase 2 clinical trials that will explore new strategies for utilizing 177Lu-PSMA-617. This therapy works by combining a radioactive isotope, lutetium-177 (177Lu), with a molecule that specifically targets prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells. It then precisely delivers radiation to cancer cells while minimizing harm to healthy tissues.
These investigator-initiated trials aim not only to explore alternative dosing and sequencing of 177Lu-PSMA-617, but also to lay the foundation for more personalized and sustainable treatment strategies.
The first trial, called , is designed to investigate a flexible dosing schedule for 177Lu-PSMA-617. This innovative approach allows for "treatment holidays" and up to 12 cycles of therapy, tailored to individual patient responses. By incorporating response assessments based on both SPECT/CT and PET/CT imaging, the trial aims to determine the optimal balance between treatment efficacy and minimizing side effects.
“With FLEX-MRT, we want to see if the flexible schedule is more effective or has other benefits compared to the fixed schedule,” said Calais, who is also an investigator in the . “We hope to provide patients with a treatment plan that is both effective and tolerable.”
The second trial, called , focuses on patients who have previously responded well to 177Lu-PSMA-617 to see if another round of the treatment can help them live longer and control the cancer better. This single-arm study will evaluate the effectiveness of a re-challenge therapy, offering up to six additional cycles of treatment. Advanced imaging techniques will help to monitor and optimize the treatment process.
“Patients with mCRPC who initially benefit from 177Lu-PSMA-617 often have few options when their cancer progresses,” Dr. Calais explained. “The RE-LuPSMA trial could provide these patients with a vital opportunity to extend their lives and maintain their quality of life.”
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