From the June 2017 issue of HealthCare Business News magazine


"When talking about prostate cancer that recurs and becomes hormone resistant, you have to lock all of the hormones in the body, which is usually done with medication, but even with these medications the tumors reoccur,” says Czernin.

The prostate-specific membrane antigen (PSMA) protein, which is found on the surface of prostate cancer and metastatic cells, was first discovered in the 1980s. It was originally labeled with Ga-68 and only used for diagnostic purposes, but eventually it was labeled with Lu-177 to also be used to treat metastatic prostate cancer.


A study from June 2015 investigating a PSMA-inhibiting theranostic agent called PSMA-617 was presented at the 2015 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging. The researchers imaged mice with Ga-68 to assess the diagnostic value of PSMA-617.

They then used Lu-177 to deliver a more powerful dose of radiation to penetrate and destroy the tumor cells when combined with PSMA-617. That preclinical research was followed by the first in-human clinical trial, which found that this therapy can reduce the prostate-specific antigen (PSA) level from 38 to 4.6 nanograms per milliliter.

Pioneering the PSMA-targeted theranostic field in Europe, a research group in Germany produced the imaging and therapeutic compounds and they were later approved for clinical use. They have been used to image thousands and treat over 1,000 patients with prostate cancer.

There’s a single-center trial underway at Frankfurt University Hospital that’s investigating PSMA for imaging and therapy, and a multi-center trial will soon begin in Germany. Most of the university hospitals in Germany are now offering this therapy to patients, says Baum.

“It’s a specific situation in Germany because we can use new radiopharmaceuticals in hospitals, especially in university hospitals, without approval by German authorities because we have a law that allows us to administer new radiopharmaceuticals to end-stage cancer patients,” he adds.

This hasn’t been approved for use in the U.S. due to the FDA’s strict regulatory requirements. UCLA and Stanford University are performing Ga-68 PSMA PET/CT exams, but therapy cannot be performed.

"We are sending out patients to Europe for treatment, which is unfortunate,” says Czernin. “There is no question that we will get [approval] fairly quickly, which will make life much easier for patients.”

This therapy has a response rate of over 80 percent, even among end-stage cancer patients, according to Baum. In addition, there are no adverse effects, which is one of the main advantages of theranostics.

June 2017 Magazine

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