Lu-177 Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application
Phase 1/2
26
about 2.8 years
18+
Male only
4 sites in CA, MD, PA
What this study is about
This trial is testing a treatment called Lu-177 Ludotadipep for men with advanced prostate cancer that has returned after other treatments. The goal is to see if this treatment is safe and effective when given in small doses, potentially leading to a recommended dose for further trial.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take [177Lu]Ludotadipep 3.7 GBq
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Dose Limiting Toxicities (DLT) with a single fixed dose of [177Lu]Ludotadipep during the first cycle (8 [±1] weeks) (Phase 1), Objective Response Rate (Phase 2a)
Secondary: Disease Control Rate (Phase 2a), European Organization for Research and Treatment of Cancer quality of life (EORTC QLQ-C30) questionnaire (Phase 2a), Pain response rate (Phase 2a), Prostate Specific Antigen Response Rate (PSA RR) (Phase 2a), Time to death for any reason (Overall Survival [OS]) (Phase 2a), Tumor response rate (Phase 2a)
Oncology