The FDA recently granted approval for gallium Ga 68 gozetotide (Locametz), a radioactive tracer crucial for PET scans identifying tumors overproducing PSMA. To qualify for Lu177-PSMA-617 treatment, patients must first undergo PET scans utilizing gallium Ga 68 gozetotide or a similar PSMA-targeted tracer to confirm their cancer’s PSMA-positive status.

A groundbreaking cancer therapy, delivering radiation directly to cancer cells, shows promise as the latest advancement in prostate cancer treatment, particularly for metastatic castrate-resistant prostate cancer, a challenging form that worsens despite standard therapies.

Results from the extensive VISION clinical trial indicate that participants receiving Lu177-PSMA-617 alongside conventional treatments experienced longer survival compared to those receiving only standard therapies—15.3 months versus 11.3 months.

Despite its success, the radiopharmaceutical treatment did lead to increased side effects, with some deaths attributed to it. However, researchers note that common side effects, like fatigue and dry mouth, were generally manageable.

Presented at the American Society of Clinical Oncology (ASCO) annual meeting and published in the New England Journal of Medicine on June 23, the VISION trial findings suggest Lu177-PSMA-617 as a potential new treatment option for metastatic castrate-resistant prostate cancer patients, according to lead investigator Dr. Michael Morris from Memorial Sloan Kettering Cancer Center.

Experts in prostate cancer treatment, such as Dr. Mary-Ellen Taplin from Dana-Farber Cancer Institute, view the VISION trial positively. However, some express disappointment over the modest improvement in patient survival.

Although awaiting FDA approval, the manufacturer, Novartis, plans to submit an application later this year.

Lu177-PSMA-617, categorized as a radiopharmaceutical, combines a drug targeting cancer cells with a radioactive particle. Its unique delivery vehicle, PSMA-617, attaches to the PSMA protein on prostate cancer cells, facilitating the internalization of the entire molecule and exposing the cancer cell to lethal radiation from lutetium-177.

PSMA is integral not only for targeted systemic radiation therapy like Lu177-PSMA-617 but also for a new imaging procedure called PSMA PET, recently approved by the FDA.

The VISION trial involved 831 individuals with metastatic castration-resistant prostate cancer, all previously treated with standard therapies. Results demonstrated improved overall and progression-free survival for those treated with Lu177-PSMA-617.

However, concerns have been raised about potential hurdles, such as defining PSMA positivity and accessibility issues related to PSMA PET imaging availability.

While awaiting FDA approval, Lu177-PSMA-617’s success in ongoing clinical trials for earlier stages of prostate cancer and in combination with other treatments, including PARP inhibitors and immunotherapy, indicates a promising future for this innovative therapy.