The investigational therapy 177Lu-PSMA-617 significantly improved radiographic progression-free survival (rPFS) and overall survival (OS) when added to standard of care treatment in patients with metastatic castration-resistant prostate cancer (mCRPC) compared with standard of care alone, according to new research.

The study was presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Despite recent therapeutic advances, mCRPC remains incurable.

Current treatment options include chemotherapy, androgen receptor blockers, and targeted therapies.

Prostate-specific membrane antigen (PSMA) is a transmembrane protein that is highly expressed in approximately 80% of patients with prostate cancer, including in metastatic disease.

With that high expression, PSMA is an attractive therapeutic target, the researchers explain.


Lutetium-labeled PSMA-617 (177Lu PSMA-617) is a radioactive compound that binds to prostate cancer cells expressing PSMA, enabling targeted delivery of radiation to the tumour and surrounding microenvironment.

VISION is a phase III international, open-label trial of 177Lu-PSMA-617 for the treatment of mCRPC that expresses PSMA.

All patients were previously treated with androgen receptor pathway inhibitors and 1–2 taxane chemotherapy regimens and a total of 831 patients were randomised 2:1 to receive 177Lu-PSMA-617 plus standard of care, or standard of care only.

The primary endpoints were PFS determined by radiography and OS.

Key Results

In the VISION trial the addition of 177Lu-PSMA-617 to standard of care significantly improved radiographic PFS, compared with standard of care alone, with a median of 8.7 months, compared with 3.4 months, respectively.

OS was also significantly improved, with the median 15.3 months versus 11.3 months.


“The findings suggest that 177Lu-PSMA-617 warrants consideration as a new standard of care n this patient population, pending regulatory review and approval,” said lead author Michael J. Morris, MD, who is the head of the Prostate Cancer Section at Sloan Kettering Cancer Center in New York.

More high-grade treatment-emergent adverse events were seen with 177Lu-PSMA-617, 52.7%, versus standard of care, 38.0%.

There were no unexpected or concerning safety signals.

"This novel targeted radiotherapy could fill a significant need for patients with metastatic castration-resistant prostate cancer that has progressed despite chemotherapy and targeted antiandrogen therapy. The success of this treatment highlights the importance of investigating alternatives to traditional types of cancer therapies,” said ASCO President Lori J. Pierce, MD, FASTRO, FASCO.

Source: ASCO