PSMA PET + MRI for Prostate Cancer

(BiPASS Trial)

This trial tests a new imaging method for detecting prostate cancer. It combines two types of scans, PSMA PET (using a tracer called 68Ga-PSMA-11) and MRI, to determine if they outperform usual methods. Men with a strong suspicion of prostate cancer, particularly those with a family history or persistently high PSA levels (a protein made by prostate cells), might be suitable candidates. Participants should not have a prior prostate cancer diagnosis and must be willing to undergo a prostate biopsy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking advancement in prostate cancer detection.

Research has shown that 68Ga-PSMA-11 is generally safe for people. Studies have found that this imaging agent for prostate cancer is well-tolerated, with most people experiencing no issues. Side effects occur in less than 1% of cases. The FDA approved it for PET scans of prostate cancer, supporting its safety. Many studies with prostate cancer patients have confirmed its safety. Overall, 68Ga-PSMA-11 has a good safety record, making it a reliable choice for detecting prostate cancer.¹²³⁴⁵

Researchers are excited about 68Ga-PSMA-11 because it offers a more precise way to detect prostate cancer. Unlike traditional imaging techniques like CT or bone scans, 68Ga-PSMA-11 targets the PSMA protein, which is highly expressed in prostate cancer cells. This means it can potentially identify cancer spread with greater accuracy. By combining this with advanced MRI, doctors might better pinpoint the cancer's location, improving treatment decisions and outcomes.

Research has shown that 68Ga-PSMA-11, a special compound, effectively detects prostate cancer. In one study, it identified cancer in 83.8% of patients. It succeeded in 60% of patients with low prostate-specific antigen (PSA) levels and in all patients with higher PSA levels. This indicates its particular effectiveness in detecting cancer in individuals with high PSA, often associated with prostate cancer. In this trial, participants will undergo mpMRI and PSMA PET scans using 68Ga-PSMA-11, which provide detailed images to locate cancer more accurately. This method can lead to better treatment decisions.⁶⁷⁸⁹¹⁰