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According to a recent Globe Newswire release, Progenics Pharmaceuticals, an oncology company that specializes in artificial intelligence and targeted therapies, announced results for its Phase 3 CONDOR study.
The Phase 3 study will further evaluate PyL which is a small molecule PET/CT imaging system that is designed to visualize prostate cancer.
Dr. Vivien Wong, V.P. of R&D at Progenics, explains that detecting metastatic lesions in prostate cancer patients which are missed in conventional imaging methods will provide improved diagnostic options for patients.
Overall, one thousand men known to have prostate cancer have been imaged with PyL.
With regard to prostate cancer, it is the most common cancer among men. The American Cancer Society reports that 174,650 new cases are identified each year with 31,620 cancer-related deaths. Yet in the United States, there are about 2.9 million men who are considered to be prostate cancer survivors.
About the Phase 3 CONDOR Study
Enrollment for the study was completed five months earlier than originally planned. The company credits the accelerated enrollment to clinical interest in improving diagnostic methods to treat recurrent biochemical prostate cancer.
The study was initiated in November 2018 and was conducted throughout fourteen locations across the U.S. and Canada. A total of 208 patients with recurrent prostate cancer have participated in this open-label study. Open-label provides transparency to researchers and patients.
(PET) Positron Emission Tomography enables visualization of soft tissue and bone tissue metastases in order to detect the absence or presence of metastatic or recurrent prostate cancer.
Cohort A of the trial examined the capability of PyL to identify prostate cancer in the pelvic lymph nodes of high-risk locally advanced prostate cancer patients.
Cohort B consists of patients with recurrent or metastatic prostate cancer. The endpoint of Cohort B is to detect the spread of cancer from its primary tumor to distant lymph nodes.
Secondary measures involve the number of participants who intend to change their prostate cancer treatment due to imaging by PyL PET/CT.
Phase 3: Disappointing Results
Progenics announced mixed results of its Phase 2/3 clinical trial of its PyL agent. Although it had met its specificity endpoint, it had failed the second endpoint: sensitivity.
Sensitivity in the CONDOR trial requires reliably detecting prostate cancer in the pelvic lymph nodes. Sensitivity was not a major issue in Cohort B as its participants were deemed to already have prostate cancer. And lastly, the secondary measurements of predictive value were strong.
The Cohort B results were encouraging enough for Progenics to announce a Phase 3 trial after consultation with the FDA. The company will use as its endpoints the measures of the Phase 2/3 trial that had proved to be successful.
Progenics is hoping that the FDA will evaluate PyL according to its predictive value instead of sensitivity and specificity.
