Biotechnology firm RadioMedix has initiated the first clinical trial for its ProstaMedix agent for the diagnosis and management of prostate cancer in U.S. patients and will begin recruiting patients this month.
ProstaMedix is a labeling agent for the PET radioisotope gallium-68 for targeting the prostate-specific membrane antigen (PMSA), which is overexpressed in most prostate cancers, the company said. The phase I and II clinical trial will evaluate the efficacy and safety of ProstaMedix in patients with suspected prostate cancer recurrence who have inconclusive bone scintigraphy, CT, or MRI exams.
Initial studies of the radiotracer have shown high sensitivity in detecting prostate cancer relapses and metastases, RadioMedix said.