Prospective REgistry of Targeted RadionucLide TherapY in Patients With mCRPC (REALITY Study)

Launched by UNIVERSITÄT DES SAARLANDES · Apr 4, 2021

Keywords

ClinConnect Summary

The REALITY Study is a clinical trial designed to learn more about the benefits and risks of targeted radionuclide therapies for men with advanced prostate cancer that has not responded to hormone treatment. This study focuses primarily on a specific type of treatment called PSMA-targeted radioligand therapy, but it also includes other therapies like Ra223 and liver-directed radioembolization. The goal is to gather information on how these treatments affect patients' survival and quality of life when used in typical clinical settings.

To participate in this study, men aged 65 to 74 who have signed a consent form and meet certain health criteria may be eligible. Key requirements include having enough specific cancer markers in their tumors and maintaining a good overall health status. Participants can expect to be monitored closely for outcomes and any side effects throughout their treatment. This research aims to provide valuable insights that can help doctors better understand how these therapies work in real life, ultimately benefiting current and future patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent form (Registry Study Inclusion Form)
• Inclusion Criteria for PSMA RLT:
• • sufficient tumoral PSMA expression defined as tracer uptake markedly higher than (physiologic) uptake in healthy liver tissue.
• • sufficient bone marrow reserve: leukocytes ≥ 2 G/L, platelets \> 75 × 109/L
• • sufficient overall patient condition: Eastern Oncology Cooperative Group (ECOG) performance status ≤ 3
• Exclusion Criteria:
• • Inability or unwillingness to provide informed consent