A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy
Status:
Not yet recruiting
Trial end date:
2032-06-15
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to study a personalized regime of prostate-specific
membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or
symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins.
The main question[s] it aims to answer are:
- To establish a dosimetry-based, personalized regime of 177Lu-PSMA
- To report on the efficacy of personalized 177Lu-PSMA
Participants will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on
renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be
escalated, to determine the regime that will be administered in the phase 2. The best
response within 12 months after the first cycle will be assessed. Salvage treatment may be
offered to responders after re-progression.