Clinical trial tests targeted radioactive agent as therapy for metastatic prostate cancer

Patient scan

Patient scan

Men with a specific type of prostate cancer that has spread following hormonal or other systemic treatments may be eligible to participate in a clinical trial at the NIH Clinical Center.

Current treatments for prostate cancer, such as chemotherapy and chemical castration with hormonal agents, can increase survival and improve quality of life for many patients. Most of these therapies, however, lose effectiveness over time. When the cancer becomes resistant to chemical castration, it may spread to other parts of the body. Prostate-specific membrane antigen (PSMA) is present on the surface of all prostate cancer cells but is highly expressed on cells of castration-resistant prostate cancer (mCRPC). Frank Lin, M.D., Investigator in the Molecular Imaging Program, is leading NCI’s effort to study the effect of targeted treatment with 177Lu-PSMA-R2 in men with mCRPC. 177Lu-PSMA-R2 molecules are composed of a radioactive segment (177Lu) linked to a targeting segment (PSMA-R2). PSMA-R2 attaches to the surface of tumor cells that express PSMA and 177Lu destroys them with radioactive particles while causing limited damage to normal cells. The first part of the study will determine the best dose of intravenous 177Lu-PSMA-R2. The second part will document the overall effect of repeated treatments, including antitumor response, safety and quality of life.

Clinicaltrials.gov identifier: NCT03490838
NCI Protocol ID: NCI-20-C-0035  
Official Title: A Phase 1/2 Open-label, Multi-center, Dose-escalation Study of Safety, Tolerability, Pharmacokinetics, Dosimetry, and Response to Repeat Dosing of 177Lu-PSMA-R2 Radio-ligand Therapy in Patients With Prostate Specific Membrane Antigen (PSMA) Positive (68Ga-PSMA-R2) Progressive Metastatic Castration-resistant Prostate Cancer, Following Previous Systemic Treatment

The Center for Cancer Research is NCI’s internal cancer center, a publicly funded organization working to improve the lives of cancer patients by solving important, challenging and neglected problems in cancer research and patient care. Highly trained physician-scientists develop and carry out clinical trials to create the medicines of tomorrow treating patients at the world’s largest dedicated research hospital on the campus of the National Institutes of Health in Bethesda, Maryland.   

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Summary Posted: Fri, 06/26/2020