Multimodal response prediction to the 177Lu-PSMA radioligand therapy with metastatic prostate cancer

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Non-invasive response biomarker study

Study drug and medical condition

• Medical condition to be studied:
  Prostate cancer metastatic

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  60

Study design details

• Main study objective:
  Prediction of response to the 177Lu-PSMA I&T therapy based on cell-tumor DNA derived from blood samples as well as routine clinical and imaging data
• Outcomes:
  prostate-specific antigen decline >50 %, progression-free survival (PFS)
• Data analysis plan:
  identification of prognostic compound (radiologic + genetic + epigenetic) biomarkers