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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Personalized 177Lu-PSMA-I\&T injected activity
Personalized 177Lu-PSMA-I\&T injected activity
Phase 1: Number of dose-limiting toxicities (DLTs)
Time frame: 12 weeks
Phase 2: Overall response rate (ORR)
Time frame: Up to 12 months
Phase 2: Biochemical response rate (PSA50)
Time frame: Up to 12 months
Frequency and grades of treatment-related adverse events (AEs)
Time frame: Up to 12 months
Delayed AEs of particular interest
Time frame: Up to 5 years
Phase 1: Overall response rate (ORR)
Time frame: Up to 12 months
Phase 1: Biochemical response rate (PSA50)
Time frame: Up to 12 months
Quality of life patient-reported outcome measures (PROMs) response rates
Time frame: Up to 12 months
Progression-free survival (PFS)
Time frame: Up to 5 years
Overall survival (OS)
Time frame: Up to 5 years
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