Telix Pharmaceuticals has finished enrolling 350 patients in a phase III study to test gallium-68 (Ga-68) prostate-specific membrane antigen (PSMA) PET for detecting prostate cancer in the pre-biopsy setting.
The BiPASS (Biopsy of the Prostate Avoidance Stratification Study) is designed to evaluate whether combining Ga-68 PSMA-PET with MRI can improve diagnostic accuracy and reduce unnecessary biopsies compared with current standard practice in a prospective, open-label trial conducted across sites in the U.S. and Australia, the company said. In earlier studies, combining Ga-68 PSMA-PET with MRI reduced unnecessary biopsies by nearly 50 percent without missing clinically significant prostate cancer, according to Telix.
The company said it has aligned with the U.S. Food and Drug Administration (FDA) on a New Drug Application (NDA) pathway for a potential new product indication for its Illuccix and Gozellix Ga-68 PSMA-PET imaging kits.
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