Top-line data from a Phase 3 study of an experimental method of visualising prostate cancer has been announced. While it met the primary endpoint for specificity, it did not meet the co-primary endpoint for sensitivity. For more detailed information about this, you can view the source press release here, at Globe Newswire.
About Prostate Cancer
Prostate cancer is (according to the source press release) the second most common form of cancer affecting men in the US. It often develops slowly, and people may not experience symptoms for several years. Typically, symptoms only begin once the prostate has grown large enough to disrupt the urethra, which carries urine.
An Experimental Method of Visualising Prostate Cancer
The company Progenics is developing an imaging compound called 1404, that is thought to work by targeting specific proteins (antigens) on the surface of more than 95% of prostate cancer cells. 1404 can then be used to create an image that may visualise the cancer. Potentially, this may be able to improve the detection and surveillance of cancer and help doctors to give patients more targeted treatment plans.
Research into 1404
1404 is being investigated in a Phase 3 trial taking place at several centres. The study is designed to evaluate how sensitive and specific 1404 SPECT/CT image assessments are at correctly identifying prostate cancer in patients. The study dosed a total of 471 patients from the US and Canada with low-grade prostate cancer.
The Top-line Results
The study found that 1404 was able to detect clinically meaningful prostate cancer with a specificity of between 71 to 75%. However, the study’s other primary endpoint of sensitivity was not met and ranged from 47 to 51%. A spokesperson for Progenics said that these results, which show low sensitivity, were “inconsistent” with the results from a previous Phase 2 study, and that the data will be thoroughly analysed to understand the new results.
For more information about the data and Progenics’ response, you can view their press release here.
