A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)

Inclusion Criteria: >18 y.o. adults able to provide consent Inoperable or metastatic PSMA-expressing cancer, with significant PSMA expression defined as uptake in at least one lesion that is superior to that of the liver on PSMA positron-emission tomography (PET) within 3 months prior to enrolment Cancer progression documented within 3 months prior to enrolment as per the investigator's assessment, without initiation of another anti-cancer treatment since (excluding palliative radiation therapy to a minority of the tumor burden), unless that anti-cancer treatment was stopped prematurely because of intolerance For participants with a cancer other than mCRPC, a recommendation from a multidisciplinary tumor board (MDT) in favor of PSMA RPT must be obtained Exclusion Criteria: Platelets < 50 x 106/L Absolute neutrophil count (ANC) < 1.0 x 106/L Eastern Cooperative Oncology Group (ECOG) 4 or prognosis < 3 months, for cancer-related or other serious medical conditions, as per investigator's assessment Known presence of central nervous system metastasis at risk of complication, which cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per investigator's assessment Any condition that would limit the ability to comply with the study protocol, as per investigator's assessment Pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)