Phase 3 Trial Testing New Imaging Agent for Prostate Cancer Detection Doses First Patient

Phase 3 Trial Testing New Imaging Agent for Prostate Cancer Detection Doses First Patient

A Phase 3 trial evaluating Progenics Pharmaceuticals‘ new imaging agent to help detect prostate cancer recurrence has begun dosing participants.

The agent, called PyL (18F-DCFPyl), is a tracing substance composed of the prostate specific membrane antigen (PSMA)-targeting agent DCFPyL coupled to a radioactive substance called fluorine F 18.

PyL is used in positron emission tomography/computed tomography (PET/CT) imaging, a diagnostic tool that uses small amounts of radioactive materials along with a special camera and computer to help evaluate organ and tissue function.

After a patient is injected intravenously (into the vein) with the tracing substance, PyL travels through the blood vessels and accumulates at prostate cancer sites, allowing clinicians to determine if the disease has returned or spread to distant organs.

“PyL has demonstrated excellent positive and negative predictive values in detecting the presence or absence of prostate cancer. This valuable information has the potential to provide earlier diagnoses, more informed treatment decisions, the ability to monitor responses, and ultimately improve patient outcomes,” Lawrence Saperstein, MD, assistant professor of radiology and biomedical imaging and chief of nuclear medicine at the Yale Smilow Cancer Hospital, and the trial’s lead investigator, said in a press release.

The open-label CONDOR trial (NCT03739684) is currently recruiting men suspected of prostate cancer relapse — those with rising PSA levels, also called biochemical relapse — at 14 clinical sites in the U.S. and Canada.

The study is planning to include 200 patients, all of whom must have negative or ambiguous findings on conventional imaging scans.

Its primary goal is to determine the agent’s predictive value in detecting the right location of new cancer lesions that confirm that the prostate cancer has returned. The findings will be compared with those of confirmatory biopsy or surgery, conventional imaging, or radiation therapy within 60 days of PyL imaging.

A secondary objective is to determine the percentage of patients whose treatment plan is changed after results of PyL imaging.

In previous studies, PyL was shown to effectively detect prostate cancer — with a true positive rate ranging from 93% to 99% and a true negative rate of 96% to 99% — that has spread to other body parts (metastases). The agent was also very well-tolerated, with no patients reporting serious adverse events.

“The initiation of this landmark trial marks an important milestone in the development of PSMA-targeted imaging agents which have the potential to transform the treatment landscape for recurrent prostate cancer,” said Mark Baker, CEO of Progenics.

“With PyL, physicians may be able to detect very small lesions that are currently missed with conventional imaging methods, which in turn could change the treatment path. We look forward to reporting data from this trial in early 2020,” he added.