The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy
Official Title: PROstate-specific Membrane Antigen DosImetry-Guided endoradiotherapY: A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)
Study ID: NCT05896371
Brief Summary: The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) 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 questions 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 (stratified by risk factors of toxicity) 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 of 3 cycles may be offered to responders after re-progression.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Jean-Mathieu Beauregard, MD,MSc,FRCPC
Affiliation: CHU de Québec - Université Laval
Role: PRINCIPAL_INVESTIGATOR