DIAGNOSTIC ALGORITHMS FOR DETERMINING AND TREATING CLINICALLY SIGNIFICANT PROSTATE CANCER BASED ON SIALYLATED AND FUCOSYLATED PROSTATE SPECIFIC ANTIGEN

Smart overview of the Invention

The patent introduces diagnostic algorithms for assessing prostate cancer risk through the analysis of specific glycosylation patterns on prostate-specific antigen (PSA). It focuses on measuring the relative amounts of α2-3-linked and α2-6-linked N-acetylneuraminic acid (Neu5Ac) on PSA in blood samples. These measurements help determine the risk level of prostate cancer, ranging from low to high, and guide decisions regarding further diagnostic procedures or treatments.

Diagnostic Methods

The methods utilize electrospray ionization mass spectrometry (ESI-MS) and center-of-mass (CoM) analysis to quantify the fractions of α2-3-linked Neu5Ac on PSA. A key threshold is set at 24% for low-risk prostate cancer (GG1) and 28% for clinically significant prostate cancer (GG2-5). Depending on these percentages, recommendations are made regarding the necessity of a needle biopsy or additional diagnostic tests.

Biopsy Recommendations

If the α2-3-linked Neu5Ac fraction exceeds 28%, a needle biopsy is recommended without further imaging. Conversely, if it is below 24%, neither a biopsy nor an MRI scan is suggested. For intermediate values between 24% and 28%, further analysis of fucosylated PSA levels determines whether a needle biopsy or an MRI scan should be pursued.

Treatment Protocols

Treatment decisions also hinge on the α2-3-linked Neu5Ac fraction. If it is above 28%, immediate biopsy treatment is advised, bypassing MRI scans. For fractions below 24%, no biopsy or MRI treatment is warranted. Intermediate values necessitate additional fucosylation analysis to decide on biopsy or MRI treatments based on further risk assessment.

Post-Surgery Monitoring

Post-prostate cancer surgery, monitoring and additional treatment decisions are guided by the same glycosylation markers. Patients with α2-3-linked Neu5Ac fractions over 28% receive further treatment, while those between 24% and 28% undergo intensified monitoring. No additional monitoring is required for fractions below 24%, indicating low risk of recurrence.